MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43/HR26 2N 36" BSC; SUTURE, SURGICAL, ABSORBABLE,

Catalog Number	833-235
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
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.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "first, a polypropylene 36in suture was used - it broke down to pieces (inside the patient) after tightening.The physician then decided to use monodek suture instead to finish the procedure.While unpacking the monodek and catching it with a "mosquito", it broke from needle separated from the suture and the suture broke down to small pieces with every touch.This happened 3 times while unpacking monodek sutures of the same box.The 4th monodek suture that was opened was ok and good for use, so the doctor finished the procedure and patient was released after a night of hospitalization for observation".No patient harm or injury.The patient status is reported as "fine".See associated mdrs 3004365956-2025-00069, 3004365956-2025-00070, 3004365956-2025-00071.
Event or Problem Description
It was reported that "first, a polypropylene 36 in suture was used - it broke down to pieces (inside the patient) after tightening.The physician then decided to use monodek suture instead to finish the procedure.While unpacking the monodek and catching it with a "mosquito", it broke from needle separated from the suture and the suture broke down to small pieces with every touch.This happened 3 times while unpacking monodek sutures of the same box.The 4th monodek suture that was opened was ok and good for use, so the doctor finished the procedure and patient was released after a night of hospitalization for observation".No patient harm or injury.The patient status is reported as "fine".See associated mdrs: 3004365956-2025-00069, 3004365956-2025-00070, 3004365956-2025-00071.
Additional Manufacturer Narrative
(b)(4).One needle that is part of the product was received for evaluation.While performing the visual inspection test it was observed that received needle was identified as product code 833-137 (mdk vi mf 0 tc43/hr26 48") of batch number: 74b2300028.Sample was not received in its original packaging.The condition reported under this customer complaint cannot be evaluated since sample was received incomplete with no suture, just the needle was received instead.A dimensional inspection of the product involved in the complaint could not be conducted since the product returned was received incompletely.A functional inspection of the product involved in the complaint could not be conducted since the product returned was received incompletely.The device history record of batch number from received sample has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The condition reported under this customer complaint cannot be evaluated since sample was received incomplete with no suture, just the needle was received instead.The timeline of this batch on received sample was reviewed, and all timing specifications were met.According to the warnings section of ifu, the product must be stored at room temperature and prolonged exposure to high temperatures must be avoided.It is unknown the storage conditions the product was subjected to after the product was shipped from teleflex.As part of the activities of this evaluation, personnel from the manufacturing process were notified for awareness of this complaint report.Additionally, as a preventive action supplier of the involved suture was notified to make them aware of this issue.Also, the sister facility where the final packaging is performed was notified of this event for awareness this complaint file will be updated if additional information is received.Complaints of this type will continue to be monitored.
Additional Manufacturer Narrative
(b)(4).One ziploc bag with biohazard labels was received, inside the bag was detected a purple suture in broken pieces without part number or batch identification and without its original packaging, it was noted that the color of sample (purple) does not correspond with characteristics of code re-ported in customer complaint.Foreign contamination is detected inside ziploc bag too.The de-vice history record of batch number from complaint report has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The condition "suture broke down to small pieces" reported under this customer complaint is de-tected in the sample, since small pieces of a broken purple suture were received in a ziploc bag for evaluation, additionally, it was noted that the color of sample (purple suture) does not correspond with characteristics of code reported in customer complaint.Customer complaint is con-firmed but at this moment issue can't be confirmed to be related to a manufacturing failure, how-ever nonconformance was open to evaluate the origin of the condition reported and document a proper action plan.As part of the activities of this evaluation, personnel from the manufacturing process were notified for awareness of this complaint report.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "first, a polypropylene 36in suture was used - it broke down to pieces (inside the patient) after tightening.The physician then decided to use monodek suture instead to finish the procedure.While unpacking the monodek and catching it with a "mosquito", it broke from needle separated from the suture and the suture broke down to small pieces with every touch.This happened 3 times while unpacking monodek sutures of the same box.The 4th monodek suture that was opened was ok and good for use, so the doctor finished the procedure and patient was released after a night of hospitalization for observation".No patient harm or injury.The patient status is reported as "fine".See associated mdrs 3004365956-2025-00069, 3004365956-2025-00070, 3004365956-2025-00071.

• Brand Name: DEK BL MF 0 TC-43/HR26 2N 36" BSC
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE,
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23896586
• Report Number: 3004365956-2025-00068
• Device Sequence Number: 12098271
• Product Code: NEW
• UDI-Device Identifier: 14026704735324
• UDI-Public: (01)14026704735324(11)220601(17)270601(10)74F2200311(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K030212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2025

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 Catalogue Number: 833-235
• Device Lot Number: 74F2200311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 03/30/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/19/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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.; N/A.
• Patient Sex: Unknown