MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOMAX VIOLET 2/0 (3) 150CM HRT30 (M); SUTURES

Model Number B0041472

Device Problems Failure To Unwrap (2940); Packaging Problem (3007)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device registered within the u.S.(b)(4).Manufacturing site evaluation: samples received: 9 open pouches.Analysis and results: there are no previous complaints of this code batch.Manufactured (b)(4) units of this code batch, there are no units in stock.Received nine open samples (only the second pack is opened).All open samples received have the first pack sealed to second pack in the 4th sealing, as can be seen on enclosed picture.This defect took place in the welding machine and these units were not sorted out by the personnel involved in this process.Final conclusion: taking into account that the open samples received does not fulfill the specifications, it is concluded that the complaint is justified.Actions on distributed product of this reference/batch: replace this code/batch to the customer or issue a refund.Corrective/preventive actions: this complaint will be included in the analysis of trending, and corrective action will be open if applies.

Event Description

Country of complaint: (b)(6).The inner package stick to the plast foil so it's not possible to "throw" it to and on the sterile table.

• Brand Name: MONOMAX VIOLET 2/0 (3) 150CM HRT30 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5763365
• MDR Text Key: 48626161
• Report Number: 2916714-2016-00542
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2020
• Device Model Number: B0041472
• Device Catalogue Number: B0041472
• Device Lot Number: 115222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Distributor Facility Aware Date: 06/30/2016
• Date Manufacturer Received: 06/01/2016
• 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
• Patient Outcome(s): Other