MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 4/0 (1.5) 45CM DS19 (M); SUTURES

Model Number C2090220

Device Problems Material Frayed (1262); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that during an ankle surgery the thread curled and frayed.

Manufacturer Narrative

Samples received: 5 unopened racepacks.Analysis and results: there are no previous complaints of this batch.We manufactured and distributed (b)(4) units of this batch.There are no units in our stock.We have received five closed samples.We have checked the thread surface of the samples received and is correct.Sewing test on artificial skin has been conducted with the samples received and it has been observed the usual behavior.Fraying does not appear when pulling the thread through the tissue.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil the specifications, we take note of this incidence in order to assess if new or additional actions are needed.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.Anyway, you will receive a credit note for the units sent.Corrective/preventive actions: 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 4/0 (1.5) 45CM DS19 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6077641
• MDR Text Key: 59124402
• Report Number: 2916714-2016-00948
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

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: 07/06/2021
• Device Model Number: C2090220
• Device Catalogue Number: C2090220
• Device Lot Number: 116273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/28/2016
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2017
• 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
• Patient Outcome(s): Other