MAUDE Adverse Event Report: B BRAUN SURGICAL SA OPTILENE 3/0 (2) 45CM DSMP16 (M) RCP; SUTURES

Model Number C3090481

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Samples received: 1 unopened racepack.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received one closed sample.We have tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): xi= (b)(4) (ep requirements: (b)(4) in average and (b)(4) in minimum).Additionally, needle attachment strength test has been conducted on the closed sample received in order to discard a faulty needle attachment during manufacturing process that could cause splitting/fraying in the thread.The needle attachment strength result fulfills the requirements of the european pharmacopoeia (ep): xi= (b)(4) (ep requirements: (b)(4) in average and (b)(4) in minimum).We have not found splitting on thread surface on the closed sample received before and after performing tests.Reviewed the batch manufacturing record, there are no incidences related to this issue and the results during the process fulfils the oem requirements.As indicated in the instructions for use of the product, when working with optilene suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.Final conclusion: although the results of the closed sample received fulfill the specifications of b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.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.

Event Description

It was reported by the healthcare professional "the costumer reports that the thread frays when passes through the tissues.It happened in 5 different patients.Carpal tunnel in hand surgery.The surgeon removed the rests of suture.The thread did not come off the needle." it was reported that there was no injury to the patient.All med watch submissions related to these patients are: 3003639970-2019-00339; 3003639970-2019-00341; 3003639970-2019-00342; 3003639970-2019-00343.

• Brand Name: OPTILENE 3/0 (2) 45CM DSMP16 (M) RCP
• Type of Device: SUTURES
• 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: 8466411
• MDR Text Key: 140613774
• Report Number: 3003639970-2019-00340
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: C3090481
• Device Catalogue Number: C3090481
• Device Lot Number: 118364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2019
• Date Manufacturer Received: 03/13/2019
• 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