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| Catalog Number |
2214 |
| Medical Device Problem Code |
Break (1069)
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| Health Effect - Clinical Code |
Foreign Body In Patient (2687)
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| Date of Event |
07/19/2024
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Product complaint (b)(4).Additional information: h6 component code: g07002 - device not received, d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information provided: one procedure device and unknown number of sterile samples returning.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Specific spinal procedure name? date of procedure? date of event where product had an issue? please describe the issue ¿ as the y connector is ¿outside the body of the patient¿ and can be typically addressed without surgery?? were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? what was the date of first activation? how was the product function verified following the first activation? who monitored the drainage and how often? was leakage detected? if so, where? was another product used? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? was a 2nd procedure performed or scheduled to remove a piece of drain left in the patient? if yes-date of procedure? findings, will piece be returned? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.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.
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Event or Problem Description
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It was reported a patient underwent an unknown spinal procedure on an unknown date in 2024 and a drain was used.Post op, the drain came apart at the y junction prematurely.Patient needed to be returned to the or to remove the drain.No further information was provided.Additional information has been requested.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Additional information: a2, a3, a4, b3.Date of event.Additional information provided b5: per user facility medwatch form, #mw5157850, the patient was one day postoperative l3-4, l4-5 laminectomy and was being prepared for discharge.The neurosurgical physician assistant was at bedside to remove bulb suction drain (blake drain) that had been placed intraoperatively.While removing blake drain, the drain tubing broke near the point of entry with a portion of the drain remaining within the incision.The neurosurgeon was immediately notified and arrived at bedside but was unable to retrieve the drain fragment.The patient was returned to the operating room for safe retrieval of retained medical device.Device is not available for return.If further details are received at a later date a supplemental medwatch will be sent.This medwatch report is in response to receipt of a voluntary medwatch report: # mw5157850.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.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Additional information: d9.Additional information: the rep informed that additional lots would be sent.Representative samples: of product code 2214 received for analysis.Quantity 2 - 2214; lot# j2309081;, quantity 10 - 2214; lot# j2308908;, quantity 1 - 2214; lot#j2308287;.Additional representative samples upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.
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Additional Manufacturer Narrative
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Product complaint#: (b)(4).Additional information: a) d4: lot: j2309081, h4: manufacture date: 28-nov-2023, d4: expiration date: 28-nov-2028, d4: primary udi number: (b)(4), b) d4: lot: j2308908, h4: manufacture date: 24-nov-2023, d4: expiration date: 24-nov-2028, d4 primary udi number: (b)(4), c) d4: lot: j2308287, h4: manufacture date: 16-oct-2023, d4: expiration date: 16-oct-2028, d4: primary udi number: (b)(4).H3: evaluation: complaint sample review: total 13 pouches (j2309081 - 2, j2308908 - 10, j2308287 - 1.) in well intact pouches (originally packed pouches) were received for evaluation.All the pouches were inspected visually, no non-conformance was noted.For reference, on pouch from lot#: j2308908, was teared-off and the product was pulled manually for tensile check, no negative observation was identified, rest packages were kept as it is.Documents review: during investigation of complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process is performed, these products are reported to be manufactured, inspected, and packaged in conformance with customer's specifications and have been found to be acceptable within all parameters.No discrepancy as per the reported defect is observed.Retention sample review: no negative observation was found.Review of defective sample's image / video: not applicable, as there was no complaint sample image / video received for evaluation.Since the received products were well intact inside the original package which was clearly indicated that the actual impacted / complaint product was not available for evaluation.Based on the investigation, it is inconclusive.As per standard practice, 100% functional test and 100% visual inspection was carried out visually before and after packing of finished goods, prior to the product release.There is no scope to miss such defect, at manufacturing / release stage.The device history records were reviewed and the manufacturing criteria was met prior to the release of each lot.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.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).H3 evaluation: further analysis of representative samples: all 13 pcs were checked for tensile strength (hub bonding test), no negative observation was identified.The device history records were reviewed and the manufacturing criteria was met prior to the release of each lot.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.
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Search Alerts/Recalls
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