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

Model Number 1050044

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

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 other technological characteristics are registered within the u.S.Similar product in us 510(k): k111959 investigation on-going.Additional information/investigation results will be provided in a supplemental report.

Event Description

It was reported that leakage of the product was noted upon opening the package.There was a blue solid substance inside the outer package.This was noted prior to application and ampuole of histoacryl was not able to be used.There was no effect on patient(s).It was reported that there were 3 of this product number and batch number noted to have the reported defect.Two pouches returned for investigation.Additional information has been requested.All medwatch reports associated with this complaint report include: 3003639970-2018-00787 (this report); 3003639970-2018-00823; 3003639970-2018-00824.

Manufacturer Narrative

We have received two open samples, the ampoules received have been optically evaluated and a defect in the tip of the ampoules was found.Tip is bent.The leakage of the glue occurs at this point.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.The results of the samples received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of failure in the samples received.Based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective and preventive actions not needed.Associated med-watch reports: 3003639970-2018-00787 (this report); 3003639970-2018-00823; 3003639970-2018-00824.

• Brand Name: HISTOACRYL BLUE 0.5ML
• Type of Device: TISSUE ADHESIVE
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8203220
• MDR Text Key: 131911853
• Report Number: 3003639970-2018-00787
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 217384N1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Distributor Facility Aware Date: 01/07/2019
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1