MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 3/0 (2) 90CM 2XHR22 CV; CARDIAC SUTURE

Model Number C2090977

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

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

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.K980703.Investigation: samples received: 1 unopened race-pack.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed 720 units in the market.There are no units in stock in b.Braun surgical's warehouse.We have received a closed sample.Needle attachment strength test results conducted with the closed sample received have values that do not fulfil the requirements of the european pharmacopoeia.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: taking into account that the results of samples received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.Actions on distributed product 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 needle detached.The reporter indicated that during preparation the needle detached.Per the reporter, a couple of times during a surgical procedure the needle detached during suturing on a patient.There was no patient injury or harm.Patient information is not available.

• Brand Name: PREMILENE 3/0 (2) 90CM 2XHR22 CV
• Type of Device: CARDIAC 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: 9176399
• MDR Text Key: 172005565
• Report Number: 3003639970-2019-00688
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2023
• Device Model Number: C2090977
• Device Catalogue Number: C2090977
• Device Lot Number: 118193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• 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