MAUDE Adverse Event Report: B. BRAUN SURGICAL SA OPTILENE 4/0 (1,5) 75CM HR17 CV RCP; SUTURE

Model Number C3090013

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: patient information: not available.Samples received: 2 unopened units.Analysis and results: there are no previous complaints of this code batch.There were (b)(4) units of this code batch manufactured and distributed in the market, no units remain in stock.Th knot pull tensile strength of the closed samples received was tested and the results fulfill the requirements of the product.Review of the batch manufacturing record was completed and they indicate this product had a normal process and the results during the process fulfill product requirements.Based on the results of the testing of the received samples this case is considered not confirmed.Corrective/preventive action is not required.

Event Description

It was reported that surgeons are unhappy with optilene sutures as the threads break very often during use.

• Brand Name: OPTILENE 4/0 (1,5) 75CM HR17 CV RCP
• Type of Device: 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 ; 3145515988
• MDR Report Key: 8148353
• MDR Text Key: 130045727
• Report Number: 3003639970-2018-00753
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2018

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: No Information
• Device Expiration Date: 05/17/2023
• Device Model Number: C3090013
• Device Catalogue Number: C3090013
• Device Lot Number: 118204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Distributor Facility Aware Date: 11/23/2018
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/10/2018
• 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