MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 6/0 (0,7) 75CM 2XDR13 CV RCP; CARDIAC SUTURE

Model Number C3095906

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K133890 samples received: there are no samples available for analysis.Analysis and results: there are no previous complaints of this code-batch.We manufactured and mostly distributed in the market (b)(4) units of this code-batch.There are 8 units in our stock that have been requested for analysis.We have not received any sample from the customer for analysis.However, we have tested the knot pull tensile strength of the samples received from stock and the results fulfil the requirements of the european pharmacopoeia (ep):0.42 kgf in average and 0.39 kgf in minimum (ep requirements: 0.15 kgf in average and 0.06 kgf in minimum).A reviewed of the batch manufacturing record for this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: when working with optilene® suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.

Event Description

It was reported the thread broke very easy.The reporter indicated that during a patch suture in a congenital duodenal obstruction (cdo) procedure the suture thread breaks very easy.There was no patient harm and everything was good.No other information has been provided.

• Brand Name: OPTILENE 6/0 (0,7) 75CM 2XDR13 CV RCP
• Type of Device: CARDIAC 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8603725
• MDR Text Key: 144828475
• Report Number: 3003639970-2019-00400
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SEE H10
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: C3095906
• Device Catalogue Number: C3095906
• Device Lot Number: 118416V013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/01/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2018
• 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