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

Model 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	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device llk540 batch number, 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 suture was used.Before opening the package, a nurse noticed that the needle had been protruded from the inner package in the sterilized package.It was not used, and another product was used for the patient.There were no adverse consequences to the patient.

• Brand Name: PRLNE BLU 4X30IN 3-0 D/A TE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9764496
• Report Number: 2210968-2020-01581
• Device Sequence Number: 2650545
• 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
• Report Date (Section B): 02/03/2020

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 Expiration Date: 09/30/2022
• Device Model Number: D9749
• Device Catalogue Number: D9749
• Device Lot Number: LLK540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1