MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 8-18" (45CM) 4-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number Z771D

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Analysis summary: one opened sample multistrand of product code z771d was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.In order to evaluate the condition of the returned sample, the labeled winding former was examined, and the needle-sutures combination belong to product code z771d for pds suture violet monofilament.No anomalies or issues related to product mix was found.A manufacturing record evaluation was performed for the finished device sampal/ z771z20 batch number, and no non-conformance were identified.Related events captured via: 2210968-2022-05047, 2210968-2022-05048, 2210968-2022-05049,2210968-2022-05050, and 2210968-2022-05052.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.The surgeon had an unusual feeling during interrupted suturing.When the surgeon checked the product, it was found that the product was not a monofilament but was shaped like a blade.The color was pale purple when compared with the normal product.This was a control release needle.There were no adverse consequences to the patient.No further information was provided.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 8/2/2022.Additional information was received: there were 4 samples from lot: sampal and 2 from lot: samrje.Same product code and characteristics this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Related events captured via: 2210968-2022-05047, 2210968-2022-05048, 2210968-2022-05049,2210968-2022-05050, 2210968-2022-05051 and 2210968-2022-05052.

Manufacturer Narrative

(b)(4).Date sent to fda: 08/05/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.A manufacturing record evaluation was performed for the finished device samrje/ z771z20 batch number, and no non-conformances were identified.(b)(4).Date sent to fda: 08/05/2022.

• Brand Name: PDS II SUTURE 8-18" (45CM) 4-0 VIO
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14886711
• MDR Text Key: 303267086
• Report Number: 2210968-2022-05051
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Z771D
• Device Lot Number: SAMRJE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1