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 when taking out a needle from the tray by holding it with a needle-holder.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: 8150678
• Report Number: 2210968-2018-77653
• Device Sequence Number: 1569580
• 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: 01/31/2019
• Device Catalogue Number: Z508G
• Device Lot Number: HE2445
• 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