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	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
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.The single complaint was reported with possible multiple events.There are no additional details regarding the additional events.The following information was requested, but unavailable: could you please confirm how many devices present the issue (mixed product)? no further information is available.What was used to complete the procedure? no further information is available.Did the procedure was completed successfully? no further information is available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a cesarean section on (b)(6) 2021 and suture was used.During the procedure, it was found that there had been suture from a different product code in a box of suture.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Date sent to the fda: 09/28/2021.Additional information: h6, h3, d9.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 investigation summary: h3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one opened box of product code z507g was received for evaluation.It was noted that the product code and lot number between the box and foil packages were different.The box belongs to product code z507g, lot number rdmcqt and the foil packets belong to product code w9105, lot number rdmbbx.All foils were opened, and the paper lid and needle/suture combination correspond to product code w9105, lot number rdmbbx.Based on the information currently available, the wrong and/or mixed packaging components were identified during the investigation of the samples received.This product issue will be addressed through quality system.

• Brand Name: PDSII CLR 18IN 4-0 S/A PS-4 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12380374
• Report Number: 2210968-2021-07774
• Device Sequence Number: 17244996
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 03/31/2026
• Device Model Number: Z507G
• Device Catalogue Number: Z507G
• Device Lot Number: RDMCQT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1