MAUDE Adverse Event Report: B. BRAUN SURGICAL SA MONOPLUS VIOLET 4/0 (1.5) 70CM DS19 (M); SUTURES

Model Number C0024536

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Date of event: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "the needle detached from the suture when it was removed from the packet." before use.No patient information.Veterinary use.

Manufacturer Narrative

Samples received: 3 unopened and 1 open pouches.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are (b)(4) units in stock in b.Braun surgical's warehouse.We have received 3 closed and 1 open samples.The open sample received is unused and only the thread and aluminum pack is available.The thread has been checked and it has been determined that it was not introduced deep enough in the needle as can be seen in the enclosed picture.This fact provoked the needle detachment.We have tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.41 kgf in average and 1.21 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum).Review of the batch manufacturing record showed this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the closed samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, taking into account that the open sample received does not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.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: MONOPLUS VIOLET 4/0 (1.5) 70CM DS19 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7957911
• MDR Text Key: 123810971
• Report Number: 3003639970-2018-00663
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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 Model Number: C0024536
• Device Catalogue Number: C0024536
• Device Lot Number: 117291
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/24/2018
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1