MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 4/0 (1.5) 90CM 2XHR17 CV; CARDIAC SUTURE

Model Number C2090902

Device Problems Material Separation (1562); Material Integrity Problem (2978)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported the thread and needle detached.The reporter indicated that the needle detaches from the thread as soon as you try to use it.There is no patient data available.No other information has been provided.

Manufacturer Narrative

Investigation: samples received: none.Analysis and results: there are no previous complaints of the same 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 for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.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: 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.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.

• Brand Name: PREMILENE 4/0 (1.5) 90CM 2XHR17 CV
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8655226
• MDR Text Key: 146535985
• Report Number: 3003639970-2019-00438
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K980703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2090902
• Device Catalogue Number: C2090902
• Device Lot Number: 116431
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/22/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1