MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 5-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8725
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a cardiovascular surgery on (b)(6) 2019 and suture was used.A foreign substance like a hair was found in the package when the package was opened.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/05/2020.Additional information: d10, h4.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary : it was reported foreign matter biological.One open sample of product code m88725, lot peh892 was received for analysis.The product code is multi-strand and required four strands double armed per packet.During visual inspection of unused sample, the folder was open and contains four strands double armed.The swage and attachment area of needles were noted to be as expected.The sutures were examined and no damaged or foreign matter were found.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to sample condition, no packaging foreign matter biological was found.

• Brand Name: PRLNE BLU 4X24IN 5-0 D/A C-1
• 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: 9485471
• Report Number: 2210968-2019-91026
• Device Sequence Number: 19184928
• Product Code: GAW
• UDI-Device Identifier: 10705031045910
• UDI-Public: 10705031045910
• 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): 11/27/2019

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: 04/30/2024
• Device Model Number: M8725
• Device Catalogue Number: M8725
• Device Lot Number: PEH892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1