MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN 1 S/A CTB CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDPB751D

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.

Event Description

It was reported that a patient underwent an unknown surgery on (b)(6) 2020 and the suture was used.During surgery, when opening the package, it was found that there had been a foreign substance like a hair.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Additional information: d10, h6.Additional h3 investigation summary: one open sample of product code pdpb751 was received for analysis.During visual inspection of the sample received, a petridish with a winding former with eight needle-suture combination and a hair was observed.In addition, the hair was separate of the sample and was not possible determine if the hair was placed in the sample.The manufacturing records could not be reviewed as the batch number is unknown.Due to condition of the sample received, it could not be determined what may have caused the reported incident.

• Brand Name: PDS PLUS VIO 8X18IN 1 S/A CTB CR
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9789831
• MDR Text Key: 198318758
• Report Number: 2210968-2020-01744
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031218871
• UDI-Public: 10705031218871
• Combination Product (y/n): N
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PDPB751D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 03/03/2020
• Patient Sequence Number: 1