MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 4/0 (1,5) 75CM DGMP19 RCP; OPTILENE NON-CARDIOVASCULAR

Model Number C3095517

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Samples received: 28 unopened race packs.Analysis and results: there are two previous complaints of this code-batch, one regarding the same issue.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have tested the knot pull tensile strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): (b)(4) in average and (b)(4) in minimum (ep requirements: (b)(4) in average and (b)(4) in minimum).We have not found splitting on the thread surface on the closed samples received before and after performing this test.Additionally, we have tested the needle attachment strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): (b)(4) in average and (b)(4) in minimum (ep requirements: (b)(4) in average and (b)(4) in minimum) however, we have found splitting on thread surface in some samples received during performing needle attachment test.Final conclusion: taking into account that the results of samples received do not fulfil the specifications of the european pharmacopeia/b.Braun surgical specifications, we conclude that the complaint is confirmed.

Event Description

It was reported the thread spliced.The reporter indicated that the thread "spliced".No other information has been provided.Clarification has been requested on the event details, however, has not yet been received.

• Brand Name: OPTILENE 4/0 (1,5) 75CM DGMP19 RCP
• Type of Device: OPTILENE NON-CARDIOVASCULAR
• 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: 8547582
• MDR Text Key: 145271879
• Report Number: 3003639970-2019-00367
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133890
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2017
• Device Model Number: C3095517
• Device Catalogue Number: C3095517
• Device Lot Number: 117165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/08/2019
• Date Manufacturer Received: 03/28/2019
• 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