MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOMEND MT 2/0 36"(90CM)DS24 (M)VPL RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number 100523567

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

It was reported an issue with monomend mt suture.The client (veterinarian) reported that when opening suture pack to use during surgery there was only a needle found, no suture.Opened another which was found to be fine.

Manufacturer Narrative

G4: reported device marketed in the u.S.Only for veterinary use, however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K011375.Summary of investigation: there is a previous complaint of this code batch, regarding needle detachment, that was closed as not confirmed (only open sample received).We manufactured and distributed in the market 8,856 units of this code batch.There are no units in stock in b.Braun surgical's warehouse.No samples available for analysis.Without closed samples and/or defective samples a proper analysis cannot be performed.Batch manufacturing record: reviewed the batch manufacturing record, this product had no incidences related to this issue and was released fulfilling b.Braun surgical specifications.Conclusion root cause analysis: it has not been possible to determine the root cause.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.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: MONOMEND MT 2/0 36"(90CM)DS24 (M)VPL 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: 18244273
• MDR Text Key: 329436467
• Report Number: 3003639970-2023-00397
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100523567
• Device Catalogue Number: 100523567
• Device Lot Number: 122196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• 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