MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 24IN 7-0 D/A BV-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	3702H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Lot #? confirm the total qty involved with suture breakage? confirm the total qty involved with suture needle pull off/detachment issue? did the reported issue occur while dispensing the suture before use on the patient or did the reported issue occur during suturing the patient? confirm if all devices involved to have reported issue during use on same single patient event/single procedure? if not, please confirm the specific number of patient events.Have any of these events been previously reported to ethicon? if yes, please provide complaint file number/ affiliate number.For each patient event please provide additional complaint details: event date, product code and lot number involved, procedure, event description, qty involved? was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed, was procedure completed successfully and how? any sample return.Etc?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The surgeon reported that the suture is fragile, easily break or detach from the needle, sometimes even when not starting to suture.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/13/2019.A manufacturing record evaluation was performed for the finished device lot number mgh647, and no non-conformances were identified.Additional h3 investigation summary: unopened samples of product code 3702, lot mgh647 were returned for analysis.The sample complaint was not received.During the visual inspection of samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed, the pull force and tensile force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no pull off suture needle or breakage suture was found, and the tested samples met the finished goods requirements.The following additional information was obtained: 1.Did the reported issue occur while dispensing the suture before use on the patient or did the reported issue occur during suturing the patient? before use.2.Confirm if all devices involved to have reported issue during use on same single patient event/single procedure? if not, 1.Please confirm the specific number of patient events 2.Have any of these events been previously reported to ethicon? if yes, please provide complaint file number/ affiliate number 3.For each patient event please provide additional complaint details: event date, product code and lot number involved, procedure, event description, qty involved? was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed, was procedure completed successfully and how? any sample return.Etc? the operating room nurse just said it's easy broken in the surgery, no further information.

• Brand Name: PRNVA BLU 24IN 7-0 D/A BV-1
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8633494
• Report Number: 2210968-2019-81700
• Device Sequence Number: 11264000
• Product Code: GAW
• UDI-Device Identifier: 10705031004597
• UDI-Public: 10705031004597
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 3702H
• Device Lot Number: MGH647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 04/28/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/13/2019
• Patient Sequence Number: 1