MAUDE Adverse Event Report: B BRAUN SURGICAL SA DAFILON BLUE 3/0 (2) 75CM DS30; SUTURES

Model Number C0935468

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Samples received: none.Analysis and results: 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 to analyze this case.Without any closed sample we cannot carry out an analysis in order to take a decision.As no samples have been received and no units are available in b.Braun surgical, s.A., we have only been able to review the batch manufacturing record and this product had a normal process and the results during the process fulfill the b.Braun surgical requirements.Needle attachment strength results before releasing the product were (b)(4) in average and (b)(4) in minimum and fulfilled the european pharmacopoeia (ep requirements: (b)(4) in average and (b)(4) in minimum).Final conclusion: without samples we are not in position of studying if the affected product does not fulfill the specifications.In consequence, a proper analysis cannot be done.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/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.

Event Description

It was reported by the healthcare professional "the thread is separated from the needle.".

• Brand Name: DAFILON BLUE 3/0 (2) 75CM DS30
• Type of Device: SUTURES
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8464015
• MDR Text Key: 140298795
• Report Number: 3003639970-2019-00318
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0935468
• Device Catalogue Number: C0935468
• Device Lot Number: 618153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Distributor Facility Aware Date: 03/18/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/29/2019
• 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