MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN UNDYED 4/0(1,5)45CM DS19 (M) RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2023204

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

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an issue with monosyn suture.The client reported that the suture thread is without needle.No injury/no consequences reported.Additional information has not been provided.

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 were (b)(4).Units in stock in b.Braun surgical's warehouse that we have received for analysis.Tightness test to the closed samples received from stock has been performed and the units are tight.Needle attachment results conducted on the samples received are 1.32 kgf in average and 0.68 kgf in minimum and fulfil european pharmacopoeia requirements: 0.46 kgf in average and 0.23 kgf in minimum.Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/european pharmacopoeia and b.Braun surgical requirements.Conclusion root cause analysis: it has not been possible to determine the root cause because the closed samples received from stock comply usp/ep and b.Braun surgical requirements regarding needle attachment strength.Final conclusion: although the results of the closed samples received from stock fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Corrective measures: 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.

• Brand Name: MONOSYN UNDYED 4/0(1,5)45CM DS19 (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: 18353648
• MDR Text Key: 330874674
• Report Number: 3003639970-2023-00422
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2023204
• Device Catalogue Number: C2023204
• Device Lot Number: 1334B6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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