MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS VIOLET 2/0 (3) 70CM HR22 (M); SYNTHETIC ABSORBABLE MONOFILAR

Model Number C0024136

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have received 28 closed samples to analyze this complaint.Tightness test to the samples received has been performed and the units are tight.We have tested the needle attachment strength of the samples received and the results do not fulfil the requirements of the european pharmacopoeia.When opening the packs, we have found that the needle is detached from the thread in three of the closed samples received.We have checked these three samples and the threads seem that were escaped from the needle probably caused by a too low strength applied in the manufacturing process to attach the thread to the needle.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled 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.Actions on product distributed of this reference/batch: based on the conclusion 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.

Event Description

It was reported that there was an issue with monoplus violet suture.The client reported that the needle is detached from the thread when opening the package.The issue was found in eight different units and prior to use.The complaint comes from veterinary use.Additional information has not been provided.

• Brand Name: MONOPLUS VIOLET 2/0 (3) 70CM HR22 (M)
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10338092
• MDR Text Key: 201033641
• Report Number: 3003639970-2020-00269
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2020

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: C0024136
• Device Catalogue Number: C0024136
• Device Lot Number: 120085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• 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