MAUDE Adverse Event Report: ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 DA RB-1 8PLGT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PXX41
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
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.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: was the nurse treated for the needle prick? if yes, what treatment was provided.It was a minor stick.No medical attention needed.Nurse did not require treatment.
Event or Problem Description
It was reported that a nurse was present during an unknown procedure on (b)(6) 2018 and suture was used on the patient.During the procedure, the needle was sticking out of the side of the sterile packet and the nurse pricked herself on the sterile needle.The nurse is fine and required no medical treatment.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information has been reported.
Additional Manufacturer Narrative
Pc-000208261 date sent to the fda: 08/13/2018 additional summary: the unopened actual sample was returned for analysis.The product code pxx41 is multi-strand and contains eight strands double armed per packet.During the visual inspection of the sample, the sterile barrier was compromised due to pin holes were observed on the copolymer and top of msda folder.The sample folder was opened, it was noted that some needles were orientated vertically in the package and a needle is not parked in the foam park and this caused the holes on cavity.Based on the samples condition, the assignable cause suggests an needle out off foam park resulting in pinhole on package.

• Brand Name: EB EXC 4GRN/4WHT 30IN 2-0 DA RB-1 8PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7657442
• Report Number: 2210968-2018-74011
• Device Sequence Number: 18871172
• Product Code: GAT
• UDI-Device Identifier: 10705031049307
• UDI-Public: 10705031049307
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: No Information
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: PXX41
• Device Lot Number: LJ6748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 08/13/2018
• Patient Sequence Number: 1