MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP; SYNTHETIC ABSORBABLE BRAIDED SUTURE

Model Number C3046651

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

It was reported an issue with novosyn quick suture.The client reported that the needle almost detached from suture (thread) before used.Additional information is not available.

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 distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received an open sample that seems unused but is contaminated 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 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 only one open sample received and could not be analyzed as it was contaminated.Final conclusion: despite 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.We regret any inconvenience this issue may have caused and thank you for your collaboration.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: NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED 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: 19199842
• MDR Text Key: 341670397
• Report Number: 3003639970-2024-00150
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K170661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3046651
• Device Catalogue Number: C3046651
• Device Lot Number: 123035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• 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