MAUDE Adverse Event Report: B.BRAUN SURGICAL SA HISTOACRYL BLUE 0.5ML

Model Number 1050044

Device Problem Incomplete or Missing Packaging (2312)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Are.Manufacturing site evaluation: evaluation on going.

Event Description

Country of complaint: (b)(6).When surgeon opened the bag, it was empty, no histoacryl.Just received the empty bag, with no ampoule inside the pouch.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: none.Analysis and results: there are no previous complaints of this code batch.(b)(4).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements.In principle, the histoacryl machine for filling ampoules and packaging them into the foils is designed to detect every empty pouch and sort it out.However the sorting out depends on reliable functioning of suckers by which the empty foils will be transported out.In this case the empty foil kept sticking to the sucker although the vacuum had already ended, so the foil did not fall into the reject bin but onto the conveyor for the correct foil.So, the empty foil was packed together with all the correct foils into the boxes.This is an isolated incident and the remainder of the batch is correct.Final conclusion: this complaint is justified.Corrective/preventive.

• Brand Name: HISTOACRYL BLUE 0.5ML
• Type of Device: HISTOACRYL
• 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: 5218975
• MDR Text Key: 30983327
• Report Number: 2916714-2015-00988
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: SEENARRATIVE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 214472N1
• Distributor Facility Aware Date: 10/26/2015
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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