MAUDE Adverse Event Report: ETHICON INC. PDSII UD 18IN 3-0 S/A PS-4 PRM MP; SUTURES - ABSORBABLE

Catalog Number	Z508G
Medical Device Problem Codes	Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Investigation summary: it was reported performance pull off suture needle pre-op.An empty opened foil, a labeled winding former with an un-dispensed suture and a needle inserted in a pink sponge were returned for analysis.During the visual inspection of the sample, the swage and attachment area were as expected; however, the suture have begun with the process of disintegration; this is the cause of the needle was detached from the strand.Also, the foil was examined for visual inspection and present holes in cavity on the back- foil package due to excessive manipulation and this condition contributed to degradation of the suture.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of performance pull off suture needle pre-op is a suture degradation; due to the improper handling of package.
Event or Problem Description
It was reported that a patient underwent an unknown plastic surgery on (b)(6) 2018, and suture was used.Prior to use on the patient, the suture was easily detached from the needle.There were no adverse consequences to the patient.Upon device evaluation, the foil was examined for visual inspection and present holes in cavity on the back- foil package due to excessive manipulation and this condition contributed to degradation of the suture.No additional information was provided.

• Brand Name: PDSII UD 18IN 3-0 S/A PS-4 PRM MP
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8150691
• Report Number: 2210968-2018-77655
• Device Sequence Number: 11332648
• Product Code: NEW
• UDI-Device Identifier: 10705031061316
• UDI-Public: 10705031061316
• 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): 11/19/2018

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: 07/31/2019
• Device Catalogue Number: Z508G
• Device Lot Number: JB2695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1