MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 1 (4) 90CM HR40S (M); SYNTHETIC ABSORBABLE BRAIDED S

Model Number C0068557

Device Problems Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: 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.K122734.Investigation: samples received: 1 open sample (without pouch).Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4).There are no units in stock in b.Braun surgical's warehouse.We have received an open unused samples without a needle connected to the thread and the thread still wound on the pack.The thread has been visually analyzed and can be seen that the thread was cut (not detached from the needle).Moreover, the thread measures 59 cm and the suture should be 90cm long.We conclude that the thread was broken in the automatic winding machine and a part of the suture (needle and 29 cm of thread) were cut by the machine and not placed in the pouch.The machine took the remaining part of the thread (59 cm) and wound it in the pouch.As no other complaints have been received we consider that this is an isolated and accidental unit not correctly discarded by the winding machine.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: taking into account that the results of samples received do 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.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.

Event Description

It was reported that the thread broke.The reporter indicated that thread broke off just after needle.The event occurred prior to the surgical procedure with no patient involvement.

• Brand Name: NOVOSYN VIOLET 1 (4) 90CM HR40S (M)
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED S
• 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: silvia orus ; carretera de terrassa, 121; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 9539026
• MDR Text Key: 173460644
• Report Number: 3003639970-2019-00951
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068557
• Device Catalogue Number: C0068557
• Device Lot Number: 119307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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