MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 3/0 (2) 90CM 2XHR37 (M); OTHER SUTURE

Model Number C0090942

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received - 5 unopened pouches.Analysis and results - there are no previous complaints of this code batch.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep).Batch manufacturing records - review of the records show that this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion - although the results of the samples received fulfill the specifications, we take note of this incidence in order to assess if new or additional actions are needed.This case is considered not confirmed by evidence of the samples received.This complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

It was reported that the suture broke in 3 separate instances.During surgery at an unspecified time, the suture was broken.Patient harm or outcome was not noted.Patient data was not available.Additional information has been requested.This report refers to the second procedure.Associated medwatches: 3003639970-2019-00055; 3003639970-2019-00057.

• Brand Name: PREMILENE 3/0 (2) 90CM 2XHR37 (M)
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8264902
• MDR Text Key: 134308479
• Report Number: 3003639970-2019-00056
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K980703
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Model Number: C0090942
• Device Catalogue Number: C0090942
• Device Lot Number: 117473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/14/2019
• Date Manufacturer Received: 01/04/2019
• 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