MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 4/0 (1,5) 45CM DGMP19 RCP; OTHER SUTURE

Model Number C3095500

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation ongoing.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with suture breakage/separation from the needle.The instances occurred during a product training and there was no patient involvement.One needle detached and one suture was noted to have had a split end.This report involves the suture with the split end.Associated medwatch: 3003639970-2019-00003.

Manufacturer Narrative

Complaint description: thread detached / one thread splitted.4 closed samples and 3 used threads without needle.There are no previous complaints of this code-batch.We have received 4 closed samples and 3 used threads without needle connected (one of them shows splitting in the thread surface) and one used thread with needle connected.We have tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.11 kgf in average and 0.48 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum).However, we have seen that in two of the samples tested appears splitting in the thread of the needle-attachment area during needle attachment strength test, as it can be seen at enclosed picture.On the other hand, we have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.20 kgf in average and 1.12 kgf in minimum (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Although the results of samples received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed taking account that the samples tested show splitting.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No capa is required.This complaint is recorded for trending analysis to assess if actions are needed in the future.Associated medwatch reports: 3003639970-2019-00003 and 3003639970-2019-00029.

• Brand Name: OPTILENE 4/0 (1,5) 45CM DGMP19 RCP
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8214933
• MDR Text Key: 132512491
• Report Number: 3003639970-2019-00022
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133890
• 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: 01/22/2019

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 Expiration Date: 04/22/2022
• Device Model Number: C3095500
• Device Catalogue Number: C3095500
• Device Lot Number: 117166V004
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/09/2019
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1