MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMICRON GREEN 2/0 (3) 75CM HR26 (M); OPTILENE NON-CARDIOVASCULAR

Model Number C0026016

Device Problem Material Integrity Problem (2978)

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

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Samples received: 28 unopened race packs.Analysis and results: there are two previous complaints of this code-batch, one regarding the same issue.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have tested the knot pull tensile strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.9 kgf in average and 1.02 kgf in minimum (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum) we have not found splitting on the thread surface on the closed samples received before and after performing this test.Additionally, we have tested the needle attachment strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.53 kgf in average and 1.19 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum) however, we have found splitting on thread surface in some samples received during performing needle attachment test.Final conclusion: taking into account that the results of samples received do not fulfil the specifications of the european pharmacopeia/b.Braun surgical specifications, we conclude that the complaint is confirmed.

Event Description

It was reported the thread broke and spliced.The reporter indicated that the thread broke and "spliced" easily.No patient information or type of surgical procedure has been provided.Patient outcome was reported as good.

Manufacturer Narrative

Corrected data: g5: 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.K012201.

• Brand Name: PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
• Type of Device: OPTILENE NON-CARDIOVASCULAR
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8745908
• MDR Text Key: 151896135
• Report Number: 3003639970-2019-00511
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 07/01/2019

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 Model Number: C0026016
• Device Catalogue Number: C0026016
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/01/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1