MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 1 (4) 8X45CM HRB48 TO(M); SUTURES

Model Number M0024876

Device Problem Component Missing (2306)

Patient Problem Missing Value Reason (3192)

Event Date 04/08/2016

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: 1 open unit.Analysis and results: there are no previous complaints of this code batch.The (b)(4) units of this product were manufactured and distributed in the market, there are no units in stock.Received an open and unused pack that has been checked.In the cardboard support there are only seven sutures, all wound.The foam does contain the slot to put the suture with the number 1, nevertheless it shows no mark (hole) of the needle as can be observed in the enclosed picture.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled the oem requirements.Final conclusion: taking into account that the open sample received does not fulfil the oem 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: opened a corrective action in order to avoid this kind of incidents in the future: (b)(4).(actions taken after the production of this reference-batch).

Event Description

Country of complaint: (b)(6).One thread with needle is missing.Once the package was opened during the operation, it was confirmed that one thread with needle was missing.As it is know, 8 threads are packed in this product but one thread was missing.Due to this situation, the customer stopped using the whole thread and change it to the new replacement.According to the sales rep, there is no mark on the sponge and the mark is showing that one needle was not fixed at all.

• Brand Name: MONOPLUS VIOLET 1 (4) 8X45CM HRB48 TO(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: 5628460
• MDR Text Key: 44392262
• Report Number: 2916714-2016-00317
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/02/2016

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 Expiration Date: 11/10/2020
• Device Model Number: M0024876
• Device Catalogue Number: M0024876
• Device Lot Number: 115462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Distributor Facility Aware Date: 04/21/2016
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/03/2016
• 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