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.Analysis and results: 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): (b)(4) kgf in average and (b)(4) kgf in minimum (ep requirements: (b)(4) kgf in average and (b)(4) kgf in minimum).However, we see that in two of the samples tested there appears to be splitting in the thread at the needle-attachment area during needle attachment strength test.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 ep: (b)(4) kgf in average and (b)(4) kgf in minimum (ep requirements: (b)(4) kgf in average and (b)(4) kgf in minimum).Review of the batch manufacturing records showed that this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: the results of samples received do not fulfil the specifications of the ep/b.Braun surgical specifications, and we conclude that the complaint is confirmed taking account that the samples tested showed splitting.

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.On (b)(6) 2019, it was noted that there was another suture detachment.This report involves the third needle detachment.Associated medwatches: 3003639970-2019-00003, 3003639970-2019-00022.

• 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
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8285878
• MDR Text Key: 136863501
• Report Number: 3003639970-2019-00029
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/09/2019
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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