|
ETHICON INC. PRLNE BLU 36IN 5-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
|
Back to Search Results |
|
| Catalog Number |
8556H |
| Medical Device Problem Code |
Device Contaminated During Manufacture or Shipping (2969)
|
| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
|
| Date of Event |
01/01/2025
|
|
Type of Reportable Event
|
Malfunction
|
|
Additional Manufacturer Narrative
|
|
Product complaint#: (b)(4).H6: type of investigation: b21 - device evaluation pending.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested, and the following was obtained via: cook medical uses the sutures to manufacture cardiac grafts.No patients were involved in this issue.The two codes involved where isolated as soon as the contaminated was seen.Not all the samples isolated have been examined.However, those that have been have shown the contaminated under the microscope.Pictures attached again.The lot number with the contaminated is tebbhc.When the suture is applied to the graft it is done under a microscope, so the contaminants were first seen by the operations team then tested by the quality manager.Additional h11: customer has advised the product is not in its original sales boxes.Examples of pictures sent through for review.If other, describe: found prior to use in cook devices, if other, describe: not in a surgical procedure., patient status/ outcome / consequences: no patient involvement, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? n/a, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, if yes, describe: n/a, is the patient part of a clinical study? unknown, ip-02564677.Device property of: none, device in possession of: none.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.
|
| |
|
Event or Problem Description
|
|
It was reported that a patient underwent an unknown procedure in 2025 and suture was used.Before use on the patient, needle portion had foreign matter (microscopic particles) found on prolene suture.No adverse patient consequences were reported.Additional information was requested.
|
| |
|
Additional Manufacturer Narrative
|
|
Product complaint # (b)(4).Date sent to the fda: 12/8/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 pending evaluation of returned device.H6 component code: c22 - photo analysis.Additional information: d4, d9, h3, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: - it was reported that 155 individual sutures (approx.5 boxes) are involved.Could you please confirm how many of these devices had microscopic particles? - how many products from each lot number contained microscopic particles? - for each lot number, how many units were found to contain microscopic particles? - did the event occur during one or multiple patient procedures? - could you please confirm the lot numbers involved? - did the event occur during one or multiple patient procedures? - please provide the source or name of person providing answers to follow-up questions: cook medical uses the sutures to manufacture cardiac grafts.No patients were involved in this issue.The two codes involved where isolated as soon as the contaminated was seen.Not all the samples isolated have been examined.However, those that have been have shown the contaminated under the microscope.Pictures attached again.The lot number with the contaminated is tebbhc.When the suture is applied to the graft it is done under a microscope, so the contaminants were first seen by the operations team then tested by the quality manager.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.H3 photo summary: the product was returned to eth for evaluation.Visual analysis determined that ten unopened overwrap packets were received for analysis.Product code 8556h.During the visual inspection of the returned sample, the overwrap packets were examined under magnification and no issues related to foreign matter could be observed.Three photos were provided; all show what appears to be blue particles.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the devices were returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: since no malfunction was observed during the investigation.No corrective and preventive action (capa) is required now.
|
| |
|
Additional Manufacturer Narrative
|
|
Product complaint #(b)(4).Date sent to the fda: 1/7/2026.Corrected information: h6 investigational codes.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
| |
|
Additional Manufacturer Narrative
|
|
Product complaint # (b)(4).Date sent to the fda: 1/22/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.Corrected information: d4 (udi #, lot).H6 investigational codes submitted in follow up 1.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to eth for evaluation.Visual analysis determined that ten unopened overwrap packets were received for analysis.Product code 8556h, lot tebcsh.During the visual inspection of the returned samples, foreign matter that appears to be silicone was observed in eight needles.In the two remaining samples no anomalies or issues related to foreign matter were observed.A further analysis was performed to determine the nature of the foreign matter; results indicate the following: the extracted material matches the characteristic features of silicone, confirming strong similarity to the reference sample.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.Based on the information currently available, the foreign matter was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
|
| |
|
Additional Manufacturer Narrative
|
|
Product complaint # (b)(4).Date sent to the fda: 1/22/2026.Correction to (b)(4) g3 should be 1/14/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
| |
|
Additional Manufacturer Narrative
|
|
Product complaint # (b)(4) date sent to the fda: 4/29/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected information: h3 investigational summary in follow up 3.H3 investigational summary: the product was returned to eth for evaluation.Visual analysis determined that ten unopened overwrap packets were received for analysis.Product code 8556h, lot tebcsh.During the visual inspection of the returned samples, foreign matter that appears to be silicone was observed in eight needles.In the two remaining samples no anomalies or issues related to foreign matter were observed.A further analysis was performed to determine the nature of the foreign matter; results indicate the following: sem-eds indicate the particles are primarily silicone coating material with metal (fe, cr, ni, ti)-containing particles on the surface of the needle.Particles may have been created through laser drilling of ethalloy and fe may have also accumulated on the tooling from the transporting tape.This foreign matter could be traced to the manufacturing process.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.Based on the information currently available, the foreign matter was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
|
| |
|
Search Alerts/Recalls
|
|
|
