MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, NATURAL

Model Number	883H
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pmu338 batch number, and no non-conformances were identified.Investigation summary: it was reported that discovered a bug within the packaging.It was received for analysis an unopened sample of product code 883h, lot pmu338.During the visual inspection of the unopened sample, a foreign matter (insect dead) could be observed into the overwrap packet.The foreign matter defect has been correlated to the manufacturing process.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, it was noted that a bug was within the packaging.A new device was used to complete the case with no adverse patient consequences.No additional information was provided.

• Brand Name: GUT CHR UD 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10857463
• Report Number: 2210968-2020-09093
• Device Sequence Number: 3633978
• Product Code: GAL
• UDI-Device Identifier: 10705031021105
• UDI-Public: 10705031021105
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 10/31/2024
• Device Model Number: 883H
• Device Catalogue Number: 883H
• Device Lot Number: PMU338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/17/2020
• Patient Sequence Number: 1