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

Model Number	853H
Medical Device Problem Code	Material Separation (1562)
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 number, and no non-conformances were identified.One empty open foil and a detached needle of product code 853, lot pgk766 were received for analysis.During the visual inspection of the sample, the swage and attachment area were noted to be as expected and a suture piece still was attached to barrel needle.Additionally, marks were observed on the edge of the needle by the use of a surgical instrument.The suture was not returned for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable of the performance pull off - suture needle, suggest an improper handling of the sample.
Event or Problem Description
It was reported that the patient underwent a c-section procedure on (b)(6) 2020 and suture was used.As the surgeon was closing the "sub q" , the needle popped off of the suture at the swage.A second like device was used to complete the procedure with no patient consequences reported.

• Brand Name: GUT PL UD 27IN 2-0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9765993
• Report Number: 2210968-2020-01590
• Device Sequence Number: 16806890
• Product Code: GAL
• UDI-Device Identifier: 10705031016835
• UDI-Public: 10705031016835
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• 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: 05/31/2024
• Device Model Number: 853H
• Device Catalogue Number: 853H
• Device Lot Number: PGK766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• 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