MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. PREMILENE 2/0 (3) 75CM HR26 CV; SUTURE

Model Number C2090042

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

Needle detached from thread.

Manufacturer Narrative

There are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received 11 closed samples.We have tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.58 kgf in average and 0.58 kgf in minimum (ep requirements: 1.12 kgf in average and 0.46 kgf in minimum).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.Although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Based on the conclusion derived from investigation, it is not required to make actions in distributed product.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.

Manufacturer Narrative

This report is being submitted a second time in order to confirm fda receipt; the original acknowledgements are no longer available, although the supplemental did receive a "duplicate report" and failure message.There are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received (b)(4) closed samples.We have tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.58 kgf in average and 0.58 kgf in minimum (ep requirements: 1.12 kgf in average and 0.46 kgf in minimum).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.Although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Based on the conclusion derived from investigation, it is not required to make actions in distributed product.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.

• Brand Name: PREMILENE 2/0 (3) 75CM HR26 CV
• Type of Device: SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi (barcelona), 08191 ; SP 08191
• MDR Report Key: 7931700
• MDR Text Key: 122637540
• Report Number: 3003639970-2018-00645
• 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,Followup
• Report Date: 04/22/2020

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 Expiration Date: 11/03/2022
• Device Model Number: C2090042
• Device Catalogue Number: C2090042
• Device Lot Number: 117445
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/19/2018
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 10/19/2018; 10/19/2018
• Supplement Dates FDA Received: 01/30/2019; 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1