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

Model Number 853H

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

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 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
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9765993
• MDR Text Key: 196779207
• Report Number: 2210968-2020-01590
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031016835
• UDI-Public: 10705031016835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1