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

Catalog Number	PDPB751D
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9789831
• Report Number: 2210968-2020-01744
• Device Sequence Number: 2574783
• Product Code: NEW
• UDI-Device Identifier: 10705031218871
• UDI-Public: 10705031218871
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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,Followup
• Report Date (Section B): 02/07/2020

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 Catalogue Number: PDPB751D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1