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

Model Number 1050044

Device Problems Partial Blockage (1065); Insufficient Cooling (1130)

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

Event Date 10/13/2016

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: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).The tube of the ampoules is frozen.The glue can not flow, the tip is blocked.The device can not be used.The med watch submissions related to this report are: 2916714-2016-00920, 2916714-2016-00919, 2916714-2016-00921, 2916714-2016-00922, 2916714-2016-00923, 2916714-2016-00924, 2916714-2016-00925, 2916714-2016-00926.

Manufacturer Narrative

Samples received: none.Analysis and results: there are two previous complaints of this batch and also one complaint received around the same time as this complaint but from other customer.(b)(4) units were manufactured and distributed in the market.There are no units in stock.Although no samples are received for this complaint, in the ampoules received in the previous complaints, there were polymerization nuclei along the cannula that caused the obstruction of the cannula.Aging studies were performed with the purpose of provoking the complained defect and study the influence of environmental conditions in its apparition.Ampoules were stressed for 9 days at 40ºc and 30 % rh.After 4 days of exposure, the stress conditions caused the apparition of some polymerization nuclei along the cannula in the ampoules.However, the liquid glue could still pass through the cannula, that was not obstructed.After 9 days of exposure, the polymerization nuclei observed caused the obstruction of the cannula.In conclusion, the environmental conditions influence the apparition of the polymerization nuclei along the cannula.A temperature of 40ºc caused the formation of polymerization nuclei along the cannula and the obstruction of the cannula after 9 days of exposure.Therefore, and according the instructions for use, histoacryl should be stored at ambient temperature below 22ºc.The ampoule containing the adhesive should only be removed from the aluminium pouch immediately prior to application.Final conclusion: taking into account that the samples received does not fulfill b.Braun surgical specifications, we conclude that the complaint is justified.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.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: 6089816
• MDR Text Key: 59509577
• Report Number: 2916714-2016-00923
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: NARRATIVE
• 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: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• 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: 215212N1
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/21/2016
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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