MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. SUPRAMID BLACK 4/0 (1.5) 45CM DS12; OTHER SUTURES

Model Number G0712086

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported an issue with the product supramid: the reporter indicated that the thread has come loose from the needle.No further information received.

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.Summary of investigation: 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 our stock.We have not received any sample for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils usp/ep and b.Braun surgical requirements.Conclusion root cause analysis: it has not been possible to determine the root cause because samples have not been received.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 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: SUPRAMID BLACK 4/0 (1.5) 45CM DS12
• Type of Device: OTHER SUTURES
• 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: 18578682
• MDR Text Key: 333700941
• Report Number: 3003639970-2024-00023
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: SEE H10
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G0712086
• Device Catalogue Number: G0712086
• Device Lot Number: 622272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• 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