MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 3-0 D/A TE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9749
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	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mkm753 batch number, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.It was found that the needle had been protruded from the paper package.Further details are not provided.The device was not used on the patient.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: an opened sample of product code d9749, lot # mkm753 was received for evaluation.During the visual inspection of the sample, the needles were noted out of the folder, however they are not in an area that could be sealed in the overwrap packet, no pin holes were noted, and the sterile barrier was not compromised.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to visual inspection of the sample, the assignable cause of the reported complaint is a needle out of the paper folder.

• Brand Name: PRLNE BLU 4X30IN 3-0 D/A TE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9180341
• Report Number: 2210968-2019-88570
• Device Sequence Number: 19486593
• Product Code: GAW
• UDI-Device Identifier: 10705031034587
• UDI-Public: 10705031034587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 09/16/2019

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: 08/31/2023
• Device Catalogue Number: D9749
• Device Lot Number: MKM753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1