MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 4-0 S/A PS-4 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z507G
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device qbmaej batch number, and no non-conformances were identified.Summary: an opened sample of product code z507, lot # qbmaej was returned for evaluation.During the visual inspection of the sample, the tail suture extends completely through the entire seal margin and the sterile barriers was compromised.According to visual inspection and sample condition the assignable cause is a suture in the seal pictures were received for evaluation.During the visual inspection of the pictures, was noted that the tail suture extends completely through the entire seal margin.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2020 and the suture was used.During the surgery, it was found that the suture had been caught at the edge of the package.When opening the package, the suture fell onto an unclean area with the package.The surgeon was guessing that the suture might have been caught at the edge of the package when the package had been sealed.The provided photo was showing the suture passed through the sealing area.There were no adverse patient consequences reported.

• Brand Name: PDSII CLR 18IN 4-0 S/A PS-4 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10466568
• Report Number: 2210968-2020-06493
• Device Sequence Number: 2391151
• Product Code: NEW
• UDI-Device Identifier: 10705031061293
• UDI-Public: 10705031061293
• 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
• Report Date (Section B): 07/29/2020

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: 01/31/2025
• Device Model Number: Z507G
• Device Catalogue Number: Z507G
• Device Lot Number: QBMAEJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1