MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	699G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
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.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 the patient underwent a nephrology procedure on (b)(6) 2019 and suture was used.The suture was detached from the needle during interrupted suturing, and the suture fell.It was not a control release needle.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 02/21/2020.Additional information: d10.H3 evaluation: an empty labeled winding former and a dispensed suture of product were received for evaluation.During the visual inspection of the dispensed suture, end was observed with damage (dent) and lineal cut that appears to be by use of a surgical instrument.The needle was not received for evaluation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the suture needle pull off suggest an improper handling and the reported complaint was by an external cause.

• Brand Name: ETHLN BLK 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9582226
• Report Number: 2210968-2020-00322
• Device Sequence Number: 328149
• Product Code: GAR
• UDI-Device Identifier: 10705031008625
• UDI-Public: 10705031008625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/18/2019

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: 05/31/2024
• Device Model Number: 699G
• Device Catalogue Number: 699G
• Device Lot Number: PGQ109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1