MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 7/0 (0,5) 45CM DSMP11 (M) RCP; OTHER SUTURE

Model Number C3090606

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2019

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.Investigation: samples received: 4 unopened race-packs.Analysis and results: there are no previous complaints of this code-batch.We manufactured 396 units of this code-batch.There are 108 units in our stock.We have received four closed samples for analysis.We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep):0.21 kgf in average and 0.208 kgf in minimum (ep requirements: 0.10 kgf in average and 0.036 kgf in minimum).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.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 breaks very easy intraoperatively.During an eyelid lift/eyelid procedure, the thread breaks very easy.No patient harm.No other information has been provided.

• Brand Name: OPTILENE 7/0 (0,5) 45CM DSMP11 (M) 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8606144
• MDR Text Key: 146370327
• Report Number: 3003639970-2019-00408
• 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

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: C3090606
• Device Catalogue Number: C3090606
• Device Lot Number: 118161V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/03/2019
• Device Age: 11 MO
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• 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