MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS C VIOLET 2/0 (3) 25M; SYNTHETIC ABSORBABLE MONOFILAR

Model Number F0024272

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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.(k031216).If additional information becomes available a follow-up report will be submitted.

Event Description

It was reported that there was an issue with monoplus violet suture.The client reported that the thread keeps breaking.Veterinary case.No more information has been provided.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received an open and used cassette.The date of cassette's opening written is: (b)(6) 2020.The cassette is within the 4 months since opening of which the cassette can be used.We have tested the knot pull tensile strength of the thread in thecassette received and the results fulfill the requirements of the european pharmacopoeia (ep): 3.35 kgf in average and 3.19 kgf in minimum (ep requirements: 2.73 kgf in average and 1.37 kgf in minimum).Reviewed the batch manufacturing record, this product had a normalprocess and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the sample received fulfil thespecifications of european pharmacopoeia/ b.Braun surgicalspecifications, we take note of this incidence in order to assess if newor additional actions are needed.The case is considered not confirmed by evidence of the sample received.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed of this reference/batch: based on theconclusion derived from investigation, it is not required to make actions in distributed product.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 C VIOLET 2/0 (3) 25M
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 11100089
• MDR Text Key: 241781876
• Report Number: 3003639970-2020-00478
• Device Sequence Number: 1
• Product Code: NEW
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F0024272
• Device Catalogue Number: F0024272
• Device Lot Number: 120235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1