MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN VIOLET 5/0 (1) 70CM HR13 (M).RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2022008

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported an issue with monosyn suture.The client reported that when the package was opened, there was no needle, just the thread.There was no patient involvement.

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Manufacturer Narrative

Summary of investigation: there are no previous complaints of this code batch of which we manufactured and mostly distributed in the market (b)(4) units.There are 20 units in stock in b.Braun surgical's warehouse.We have received an open and unused sample with the needle detached from the thread (thread is not wound on the pack and needle is missing).However, without closed samples a proper analysis cannot be performed.Considering that no other customer complaints have been received concerning this issue for this code-batch, we consider that this is an isolated unit, but the whole batch is correct.Batch manufacturing record: reviewed the batch manufacturing record, this product had an incidence not related to this issue and the product was released fulfilling b.Braun surgical requirements.Needle attachment strength results conducted on samples before releasing the product were 0.82 kgf in average and 0.73 kgf in minimum and fulfilled the requirements of the european pharmacopoeia: 0.23 kgf in average and 0.11 kgf in minimum.Conclusion root cause analysis: the root cause cannot be determined as no closed samples have been received and only one open sample received.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.Corrective measures: 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.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: MONOSYN VIOLET 5/0 (1) 70CM HR13 (M).RCP
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR SUTURE
• 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: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 18825193
• MDR Text Key: 336753338
• Report Number: 3003639970-2024-00064
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2022008
• Device Catalogue Number: C2022008
• Device Lot Number: 122513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2022
• 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