MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 4/0 (1.5) 75CM HR26 (M) CV; OTHER SUTURE

Model Number C2090040

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

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: 30 unopened racepacks.Analysis and results: there are no previous complaints of this code-batch.We manufactured (b)(4) units of this code-batch.There are (b)(4) units in stock blocked.We have received 30 closed samples from the customer for analysis.We have tested the needle attachment strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.01 kgf in average and 0.71 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum) however, we have found thread splitting near the needle attachment area in 4 of the 30 samples tested during performing needle attachment strength test.A faulty needle attachment process (too much strength applied) could cause this splitting.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: taking into account that 4 of the 30 samples received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure is some of the samples received.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/preventative actions needed.

Event Description

It was reported the needle detached.The reporter indicated that when the packet was opened the needle separated from the thread.No patient information is available as this event occurred before use in a veterinary case.

• Brand Name: PREMILENE 4/0 (1.5) 75CM HR26 (M) CV
• 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: 9214338
• MDR Text Key: 163333058
• Report Number: 3003639970-2019-00721
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: C2090040
• Device Catalogue Number: C2090040
• Device Lot Number: 117485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2019
• 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