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

Catalog Number	J714D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pem648 batch number, and no non-conformances were identified.The product upon which this medwatch is based has been received.However, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that the patient underwent a cervical excisional biopsy on (b)(6) 2019 and suture was used.The needle broke in half while attempting to suture deep dermal tissue.Changed to another device to complete the procedure.Both the broken needle and the swaged needle were retrieved from the patient.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: one empty opened foil and one labeled winding former with eight needle-suture combinations of product code j714, lot pem648 were received for analysis.The product code is control release and required eight strands per packet.During the visual inspection of eight needle-suture combination, the swage and attachment area were noted to be as expected; also, the tip and body of the needles were examined under magnification and no defects, damage or needle breakage were found.Besides, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the needles condition, no breakage needle 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: 9247185
• Report Number: 2210968-2019-89138
• Device Sequence Number: 17084658
• Product Code: GAM
• UDI-Device Identifier: 10705031042483
• UDI-Public: 10705031042483
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 04/30/2024
• Device Catalogue Number: J714D
• Device Lot Number: PEM648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1