MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 5/0 (1) 75CM DS19 (M); OTHER SUTURE

Model Number C0933236

Device Problems Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K990090.Investigation: samples received: 1 open pouch without the second pack.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) in the market.There are no units in stock in b.Braun surgical's warehouse.We have received a sample without the second pack.Only the 1st pack is available and it is closed.However, without closed samples and/or defective samples a proper analysis cannot be performed.As no samples have been received and no units are available in b.Braun surgical, s.A.We have only reviewed the batch manufacturing record and the results during the process fulfill usp/ep and b.Braun surgical requirements.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 analyze it.Please note that when no samples are received our analysis is very limited.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.No corrective/preventive actions needed.

Event Description

It was reported that the pack sticks.The reporter indicated that the products stick/are sealed on the overpouch pack.The event occurred prior to use with no patient injury or harm.

• Brand Name: DAFILON BLUE 5/0 (1) 75CM DS19 (M)
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa, 121; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 9539027
• MDR Text Key: 173460265
• Report Number: 3003639970-2019-00949
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: C0933236
• Device Catalogue Number: C0933236
• Device Lot Number: 619255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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