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

Model Number	JB724
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 the patient underwent an unknown ob-gyn procedure on (b)(6) 2019 and suture was used.During the procedure, it was found that the needle had been detached from the suture.It was a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/31/2020.Additional h3 investigation summary: one paper lid and one winding former with eight used needles of product code jb724 were returned for analysis.During the visual inspection of eight used needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined under 20x magnification and no suture remnant was found ; however, slightly marks on the body of needle that appears to be by the use of a surgical instrument and body fluids were observed.Additionally, the suture was not returned for evaluation.In addition, there is not sign of detachment in the needles since all needles present marks of surgical instrument and body fluids, is not possible determined which of the needles is the complaint needle.The manufacturing records could not be reviewed as the batch number is unknown.According to sample condition,it could not be determined if the needles were detached before minimum requirement or met with the requirement since is control release product.

• Brand Name: VCL CT BRD UD 8X18IN 0 S/A CTXB 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: 9378262
• Report Number: 2210968-2019-90338
• Device Sequence Number: 3103647
• Product Code: GAM
• UDI-Device Identifier: 10705031043954
• UDI-Public: 10705031043954
• 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): 11/11/2019

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 Model Number: JB724
• Device Catalogue Number: JB724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1