MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A SC-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	DC340
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Lot number mjz475 which corresponds to the product code j493g.The complaint product is dc340.Can you provide a photo of the product dc340 with lot number? do you have any sample for evaluation?.
Event or Problem Description
It was reported that the patient underwent a finger laceration procedure on unknown date and suture was used.On the first attempt to stitch, the needle came off thread.It was removed from finger intact.The provider ended up switching to non-absorbable sutures to avoid further issues with this product.There were no adverse patient consequences reported.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A SC-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9759425
• Report Number: 2210968-2020-01555
• Device Sequence Number: 11390804
• Product Code: GAM
• UDI-Device Identifier: 10705031036215
• UDI-Public: 10705031036215
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

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 Model Number: DC340
• Device Catalogue Number: DC340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1