MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A.U. NOVOSYN CHD VIOLET 2(5) 90CM HR65(M) DDP; SYNTHETIC ABSORBABLE BRAIDED SUTURE

Model Number B1068640

Device Problems Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

It was reported an issue with novosyn chd suture.The client reported that the outer and inner packaging were welded.This makes it difficult to correctly place the thread on a clean table - during or before the surgery when throwing the package away.There was no patient involvement.

Manufacturer Narrative

Reported device not marketed in the us, however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the us.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.We manufactured (b)(4) units of this code-batch.There are 216 units in our stock that have been blocked.We have received 176 closed samples and 2 open and unused samples, only the second pack is opened.Tightness test to the closed samples received has been performed and the units are tight.The open samples received do not have the aluminum pouch stuck to the outer paper foil.However, we have opened the closed samples received and we have found that in some units, the first pack (aluminium) is sealed to the second pack (paper foil) in the 4th sealing.This is due to an accidental effect in the welding machine and these units were not sorted out by the personnel involved in this process.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Final conclusion: taking into account that the results of closed samples received do not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in the closed samples received.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: NOVOSYN CHD VIOLET 2(5) 90CM HR65(M) DDP
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.U.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.U.; 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: 12966474
• MDR Text Key: 282204486
• Report Number: 3003639970-2021-00585
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: B1068640
• Device Catalogue Number: B1068640
• Device Lot Number: 121112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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