MAUDE Adverse Event Report: TELEFLEX MEDICAL MDK VI MF 0 TC43/HR26 48"; SUTURE, SURGICAL, ABSORBABLE,

Model Number	IPN000864
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).A visual, dimensional, nor functional inspection of the product involved in the complaint could not be conducted since the product was not returned.No issues or discrepancies were found in the device history record of product code 833-137 / batch 74l2102767 that can be related to the failure mode reported.Incoming inspection records of the needle lot involved in the manufacturing of product code 163625ph / batch 3200649200 were reviewed, no issues or discrepancies were found.Also, vendor record of the suture lot involved in the manufacturing of product code dmmv100/batch m210728vb2-300r were reviewed, no issues or discrepancies were found.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility is not being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
Medwatch report# (b)(4).Dart portion at the end of suture broke off and resulted in a retained foreign body.Disclosed to family and patient and decision to leave in place was made.Another similar incident occurred but the dart was retrieved.

• Brand Name: MDK VI MF 0 TC43/HR26 48"
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE,
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 14685379
• Report Number: 1036844-2022-00042
• Device Sequence Number: 17495451
• Product Code: NEW
• UDI-Device Identifier: 14026704603920
• UDI-Public: 14026704603920
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K030212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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: 11/29/2024
• Device Model Number: IPN000864
• Device Catalogue Number: 833-137
• Device Lot Number: 74L2102767
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown