MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 5/0 (1) 90CM 2XHR22 CV RCP; SUTURES

Model Number G3090975

Device Problems Break (1069); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It is reported that the thread breaks easily and the needle is bent.

Manufacturer Narrative

Samples received: 1 unopened racepack.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 540 units of this code-batch.There are no units in our stock.We have received 1 closed sample to analyze this complaint.We have tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): xi= 0.79 kgf (ep requirements: 0.31 kgf in average and 0.10 kgf in minimum).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".On the other hand, the needles of the sample received (reference with double needle) have been tested for bending strength and the results fulfill product specifications: 3.63 nxcm and 3.82 nxcm in minimum.Minimum bending strength specification: > 3.1 nxcm.Remarks: care should be taken to avoid damage when handling surgical needles.Grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage.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: although the results of the sample received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: OPTILENE 5/0 (1) 90CM 2XHR22 CV RCP
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7688053
• MDR Text Key: 114030978
• Report Number: 3003639970-2018-00402
• 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: 07/30/2018

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: 02/19/2021
• Device Model Number: G3090975
• Device Catalogue Number: G3090975
• Device Lot Number: 116075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Distributor Facility Aware Date: 06/25/2018
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other