MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV RCP; CARDIAC SUTURE

Model Number C3090545

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 08/09/2019

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.K133890.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported the thread broke very easily during knotting.The reporter indicated that during a surgical procedure while suturing a vessel at the arm, the thread broke very easily during knotting.No patient harm and everything is fine.Additional information not available.

Manufacturer Narrative

Samples received: there are no samples available.Analysis and results: the involved batch number is not known.The possible batches are: 115454, 115467, 116063, 116133, 116453, 117234, 117302, 117381, 117394, 117502, 118435 and 119031.There are no previous complaints of the batches 115454, 116063, 116453, 117234, 117302, 117502 nor 119031.There is one previous complaint regarding the same issue for the batch 115467 (closed as not confirmed) and one previous complaint regarding other issue for the batch 116133 and another for batch 118435.We manufactured (b)(4) units of the batch 115454, 1,080 units of the batch 115467, 828 units of the batch 116063, 936 units of the batch 116133, 972 units of the batch 116453, 1,044 units of the batch 117234, 1,008 units of the batch 117302, 972 units of the batch 117502, 972 units of the batch 118435 and 864 units of the batch 119031.There are only 24 units in stock of the batch 116453 and 36 units in stock of the batch 117502.There are no units in stock of the other possible batches.We have not received the involved batch nor any sample for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.Reviewed the batch manufacturing records of the possible batches, no incidences have been found that could cause this issue 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 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 analyse 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: OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9039554
• MDR Text Key: 158809671
• Report Number: 3003639970-2019-00650
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090545
• Device Catalogue Number: C3090545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1