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

Model Number 1050044

Device Problem Partial Blockage (1065)

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

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 that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the glue does not flow through the tube, the tip had to be cut off.

Manufacturer Narrative

Samples received: 3 unopened and 1 opened pouches.Analysis and results: there is one previous complaint of this code batch.(b)(4) units of this product were manufactured and distributed in the market, there are no units in stock.The four received complained ampoules were optically evaluated.All ampoules were affected.The observed defect is thought to be consequence of moisture diffusing inside the ampoule area, most probably, through the thinnest area of the cannula-tip transition, thus provoking glue polymerization along the cannula and hindering the pass of the liquid glue through the cannula.The defect would be theoretically promoted by humid conditions and/or high temperatures, thought it cannot be concluded that this is the root cause of the defect.Batch manufacturing record of the involved reference-batch has been checked and no deviations have been found.Final conclusion: taking into account that the results of samples received do not fulfill the specifications, we conclude that the complaint is justified.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: HISTOACRYL BLUE 0.5ML
• Type of Device: TISSUE ADHESIVES
• 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: 6176652
• MDR Text Key: 62470953
• Report Number: 2916714-2016-01032
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NARRATIVE
• 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,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 215161N1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/01/2016
• Date Manufacturer Received: 12/19/2016
• 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