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

Model Number 1050052

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).Skin glue was also introduced with good response from the radiologists.No feedback from cancer day unit in regards to post operative care.Port was accessed at times immediately after insertion and alcoholic cleaning used and appeared to be contradicted to wound healing.Glue has been cased and returned to double suturing as wound should be left for 7 days.

Manufacturer Narrative

Samples received: no samples are available analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in b.Braun surgical's warehouse.The information received suggests that the use of an alcoholic cleaning solution may be contradicted with the wound healing.Please refer to the instructions for use of the product: in "precautions" says (.) the areas to be joined should be as dry as possible.Moisture may accelerate histoacryl polymerization and might affect wound closure results.Any remaining of topical medications/anaesthetics must be removed prior to application.In the "warnings" says (.) histoacryl should not be applied to wet or bleeding wounds.Excess moisture (such as water or alcohol) or blood presence, may accelerate polymerization in the generation of excess heat.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.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 TISSUE ADHESIVE 0.5ML
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7371843
• MDR Text Key: 103569692
• Report Number: 3003639970-2018-00191
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050052
• Device Catalogue Number: 1050052
• Device Lot Number: 217254N3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2018
• Date Manufacturer Received: 03/07/2018
• 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