MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 3/0 (2) 45CM DS24; OTHER SUTURE

Model Number C0932353

Device Problems Dull, Blunt (2407); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported an issue with dafilon suture.The customer reported that the thread used has a needle that does not pierce very well, in addition to prolonging suturing times, it causes trauma to the patient's skin, worsening the effectiveness of the synthesis and the final result.Also, the thread breaks during use and this is very serious, as more than one thread is often needed to complete tissue synthesis (as well as prolonging operating times).It occurred during intradermic suture on the skin of the neck.In addition, after 10 days, the patient who has to remove the stitch has a high risk of the stitch remaining in the surgical wound with possible infection of the wound (as the thread can break very easily).The client specifies that the same problem occurs frequently.The reported consequences were prolongation of the operation time, worse outcome for the patient, use of several threads to achieve the skin synthesis, the higher risk of permanence of part of the thread inside the wound after its removal, which can lead to a high risk of infection and its possible consequences.The patient's current outcome is good.

Manufacturer Narrative

Analysis and results: there are no previous complaints of the same reference-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have received two closed samples to analyze this case.We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 2.03 kgf in average and 1.96 kgf in minimum (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum) these values are the usual and current ones for this thread and size.As stated in precautions of the instructions for use of the product, "when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked." reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.The needles of the closed samples received have been checked (tips, edges, and geometry) and are conform to the specification.However, both needles have been tested for penetration performance and the average result is: 0.530 n.This result is slightly higher than the penetration strength specification value (< 0.480 n).The needle manufacturer has not been able to identify a root-cause.Reviewed the complaint history records, there are no previous complaints in any of the several products manufactured with the same needle raw material batches used in this product regarding needle blunt/deficient punction.There are also no previous complaints in any of the several products manufactured with the same thread raw material batch used in this product regarding thread breakage.Final conclusion: taking into account that the samples received do not fulfil b.Braun surgical specifications regarding needle blunt defect, we conclude that the complaint is confirmed by evidence of the failure in the samples received.Regarding thread breakage defect, according to the results of the tests realized to the closed samples and the batch manufacturing record review, the product complies with our specifications; therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.Nevertheless, we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: DAFILON BLUE 3/0 (2) 45CM DS24
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 14468881
• MDR Text Key: 292355357
• Report Number: 3003639970-2022-00222
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K151165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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
• Device Operator: Health Professional
• Device Model Number: C0932353
• Device Catalogue Number: C0932353
• Device Lot Number: 621475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1