MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 4-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J714D
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
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 an unknown surgery on (b)(6) 2020 and suture was used.During the procedure, when opening the package, it was found that there had been a foreign substance like a hair.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: 04/29/2020.H3 evaluation: one open sample of product was received for analysis.The product code is multi-strand and required eight strands per packet.During visual inspection of the sample, the winding former contained eight strands.The swage and attachment area of needles were noted to be as expected.The sutures were dispensed and examined along strand with no defects or foreign matter 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 foreign matter was found.

• Brand Name: VCL CT BRD UD 8X18IN 4-0 S/A RB-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9985719
• Report Number: 2210968-2020-03338
• Device Sequence Number: 4355373
• Product Code: GAM
• UDI-Device Identifier: 10705031042483
• UDI-Public: 10705031042483
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 03/30/2020

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: J714D
• Device Catalogue Number: J714D
• Device Lot Number: PGK173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1