MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 2 (5) 150CM HR65 (M) .RCP; PREMILENE NON-CARDIOVASCULAR

Model Number B2095585

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510k: k980703.Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a suture broke postoperatively.About 2 hours after a veterinary surgery, it was noted that the premilene suture had snapped and an area of tissue had opened.The procedure had been performed on a calf with an unspecified umbilical issue.This malfunction required a re-operation to repair the incision.The calf's condition was then "ok".The veterinarian was concerned about an increased risk of infection due to a second procedure.No further information was provided.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: analysis and results: there is a previous complaint of this code batch regarding thread breakage during surgery.It was closed as not confirmed after the analysis.There are no units in stock in b.Braun surgical's warehouse.We have received 11 closed and 2 open units.One of the open samples received is unused and the other is used with the threads broken, knots are not undone.We have tested the knot pull tensile strength of the closed samples received (and unused open sample) and the results fulfill the requirements of the european pharmacopoeia (ep).Review of the batch manufacturing records showed this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Remarks: as indicated in the instructions for use of the product: "when working with premilene suture materials great care should be taken to ensure that the use of surgical instruments, such as forceps and needle holders, do not cause any crushing or crimping damage to the suture material".Final conclusion: although the results of the samples received fulfil the specifications of ep/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.

• Brand Name: PREMILENE 2 (5) 150CM HR65 (M) .RCP
• Type of Device: PREMILENE 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
• MDR Report Key: 8221888
• MDR Text Key: 132524427
• Report Number: 3003639970-2019-00020
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• 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,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: B2095585
• Device Catalogue Number: B2095585
• Device Lot Number: 114252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/02/2019
• Date Manufacturer Received: 01/09/2019
• 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