MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43 2N 48" BSC; DEKLENE MAXX POLYPROPELENE NON

Catalog Number	833-234
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the capioslim device was sutured and fired.After that, the thread breaks during fixation.The thread was replaced with a new one, but the same reproducibility occurs.An investigation was requested to determine the cause of the problem.The procedure was completed without any problems using another lot.The two broken threads were collected, and an analysis was requested".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the capioslim device was sutured and fired.After that, the thread breaks during fixation.The thread was replaced with a new one, but the same reproducibility occurs.An investigation was requested to determine the cause of the problem.The procedure was completed without any problems using another lot.The two broken threads were collected, and an analysis was requested".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: DEK BL MF 0 TC-43 2N 48" BSC
• Common Device Name: DEKLENE MAXX POLYPROPELENE NON
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19975452
• Report Number: 3004365956-2024-00056
• Device Sequence Number: 15599829
• Product Code: GAW
• UDI-Device Identifier: 14026704735317
• UDI-Public: (01)14026704735317(11)220607(17)270608(10)74F2200931(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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
• Device Catalogue Number: 833-234
• Device Lot Number: 74F2200931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown