MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 45CM DS19; OTHER SUTURE

Model Number C0932205

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the dafilon suture after a skin biopsy.One week postoperatively, the wound was still gaping and the physician removed the suture immediately.It was not clear why the dehiscence had occurred.There was no additional information provided.

Manufacturer Narrative

D4 expiration date: 07/27/2023.Manufacturing evaluation: samples received: one unopened pouch to analyze the six cases (b)(6)).Analysis and results: there are no previous complaints of this code-batch.There are no units in our stock.We have received one closed sample to analyze the six cases.We have tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep).This value is the usual and the current one for this thread and size.We have also tested the knot security control of the closed sample received and the result is into the current range for this thread and size.Remarks: as stated in the instructions for use (ifu) of the product, "dafilon should be used applying the standard surgical suturing and knotting techniques, taking into account the surgeon's experience with the respective surgical procedure.Care should be taken that the knots are positioned properly and adequate knot security is given".On the other hand, "the following side effects may be associated with the use of this product: tissue injury, transitory local irritation, transient inflammatory foreign body reaction, enhanced bacterial infectivity, wound dehiscence, hypertrophic scar/granuloma formation, track bleeding, increased risk of aneurism and stenosis".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.Final conclusion: according to the results of the sample tested and the batch manufacturing record review, the product complies with our specifications and also fulfill usp/ep requirements.Therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.

• Brand Name: DAFILON BLUE 4/0 (1.5) 45CM DS19
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8884182
• MDR Text Key: 153994341
• Report Number: 3003639970-2019-00600
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932205
• Device Catalogue Number: C0932205
• Device Lot Number: 618305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention