MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 7-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EP8734H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cabg procedure (b)(6) 2022 and suture was used.During the procedure, the inner needle at both ends of the product detached the moment the surgeon held it.A new package was used for vascular anastomosis, and after continuous suturing on lad, when the surgeon was about to pass the needle-suture to a scrub nurse, the needle detached from the suture again and fell into the patient's pleural cavity.It took several minutes to find the fallen needle and there was no residue in the patient's body.These were not control release needles.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested, but unavailable: was additional dissection required in other tissues other than the target tissue to remove the needle? if yes, please describe: no further information is available.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain: no further information is available.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? no further information is available.Was the procedure completed successfully? no further information is available.What is the patient¿s current status? no further information is available.No further information will be provided." additional information was requested, and the following was obtained via: no patient damage occurred with the first needle used.No surgical action was taken during the search for the second needle (this was the needle-suture which was used for vascular anastomosis).The patient has been discharged from the hospital already and has no complaints about the event.Events reported via: 2210968-2022-05394.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/9/2022.Additional information: d9, h3, h4, h6.H6 component code: g07002 no device problem found a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, but unavailable: was additional dissection required in other tissues other than the target tissue to remove the needle? if yes, please describe no further information is available.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.No further information is available.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? no further information is available.Was the procedure completed successfully? no further information is available.What is the patient¿s current status? no further information is available.No further information will be provided." additional information was received: no patient damage occurred with the first needle used.No surgical action was taken during the search for the second needle (this was the needle-suture which was used for vascular anastomosis).The patient has been discharged from the hospital already and has no complaints about the event.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that one suture piece of product code ep8734h was received for analysis.In order to evaluate the conditions of the returned sample, the needle was not received for evaluation, and during the visual inspection of the suture, the ends were observed cut.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The condition of the sample received indicates improper handling of the device.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that two opened samples of product code ep8734h were received for analysis.In order to evaluate the conditions of the returned sample, the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issues related no defects were observed during evaluation.Functional test was performed, and the pull force result were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that two opened boxes with thirty-six and nine packets ea.Of product code ep8734h were returned with the packaging closed.Upon initial inspection, of the packets, no external damages were observed.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issues related no defects were observed during the evaluation.Functional test was performed, and the pull force result were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.Events reported via: 2210968-2022-05395 and 2210968-2022-05394.

• Brand Name: PRLNE BLU 18IN 7-0 D/A BV175-6 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14991029
• Report Number: 2210968-2022-05395
• Device Sequence Number: 1613906
• Product Code: GAW
• UDI-Device Identifier: 10705031206663
• UDI-Public: 10705031206663
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EP8734H
• Device Catalogue Number: EP8734H
• Device Lot Number: RMBACR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown