MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN VIOLET 5/0 (1) 45CM DS16 (M).RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2022419

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

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported an issue with monosyn suture.The client reported that when opening the package, there was no needle inside.Additional information has not been provided.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which 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 an open sample with the needle detached from the thread, the thread is not wound on the pack and the needle is missing.However, without closed samples a proper analysis cannot be performed.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Needle attachment strength test results conducted on samples before releasing the product were: 0.77 kgf in average and 0.68 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (0.23 kgf in average and 0.11 kgf in minimum).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.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 VIOLET 5/0 (1) 45CM DS16 (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: 18092153
• MDR Text Key: 327626433
• Report Number: 3003639970-2023-00363
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2022419
• Device Catalogue Number: C2022419
• Device Lot Number: 123062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• 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