MAUDE Adverse Event Report: B BRAUN SURGICAL SA OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV RCP; SUTURES

Model Number C3090545

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

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional" product deformed and looked flaky while opening the package.The defects were found before use." no patient involvement reported.

Manufacturer Narrative

Samples received: 21 unopened racepacks and 2 opened.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 21 closed samples and 2 open samples.We have checked the two open samples received and a part of the thread of both samples shows splitting/fraying.Furthermore, we have opened the closed samples received and we have found that 1 of the 21 that also shows a fiber out of the thread surface.Remarks: we take note of this issue and the involved personnel will be informed of the incidence.Final conclusion: we conclude that the complaint is confirmed by evidence of failure in one of the samples received.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: OPTILENE 7/0 (0,5) 75CM 2XDRC10 CV 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 ; 1 a raumantie; helsinki, MO 00350 ; FI 00350
• MDR Report Key: 8466410
• MDR Text Key: 140612729
• Report Number: 3003639970-2019-00312
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 04/11/2019

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 Model Number: C3090545
• Device Catalogue Number: C3090545
• Device Lot Number: 118421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/11/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 04/11/2019
• 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