MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	ZB346
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (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.A manufacturing record evaluation was performed for the finished device number, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent a caesarean section procedure on (b)(6) 2019 and suture was used.The suture was broken during continuous suturing on the fascia.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device evaluation summary: it was received for analysis an unopened sample of product code zb346, lot mj5293.The complaint sample was not received for evaluation.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problem and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative sample, no performance breakage suture was found and the tested sample met the finished goods requirements.

• Brand Name: PDSII VIO 36IN 0 S/A CTB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8970557
• Report Number: 2210968-2019-86657
• Device Sequence Number: 2559401
• Product Code: NEW
• UDI-Device Identifier: 10705031062047
• UDI-Public: 10705031062047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 08/13/2019

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: 07/31/2023
• Device Catalogue Number: ZB346
• Device Lot Number: MJ5293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1