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

Model Number 1050044

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: 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.K111959.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there was ampoule leakage.The reporter indicated that the head nurse of the operating room of the hospital stated that a large amount of glue leakage had been found during the operation recently.The event occurred prior to use.

Manufacturer Narrative

Investigation: samples received: (b)(4) unopened pouches.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market(b)(4) units of this code-batch.There are no units in our stock.We have received (b)(4) closed samples for analysis.We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.91 kgf in average and 1.88 kgf in minimum (ep requirements: 1.53 kgf in average and 0.92 kgf in minimum) reviewed the batch manufacturing record, this batch had an incidence but was released into the market fulfilling usp/ep and b.Braun surgical requirements.Remarks: when working with silkam suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders do not damage the material by being pinched or kinked.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Anyway, you will receive a credit note for one box of product as a quality courtesy for the units sent for analysis.No corrective/preventive actions needed.

• Brand Name: HISTOACRYL BLUE 0.5ML
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9320792
• MDR Text Key: 172322285
• Report Number: 3003639970-2019-00768
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 218161N1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1