MAUDE Adverse Event Report: AESCULAP AG HISTOACRYL BLUE 0.5ML; TISSUE ADHESIVES

Model Number 1050044

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on going.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.Are.

Event Description

Country of complaint: (b)(6).Surgeons complained about 50 pcs of histoacryl which glue cannot go out from ampoule it can't flow out when twisting off the ribbed tip of the cannula as usual.The surgeons have to cut the bottom of cannula by scissors.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 ampoule.Analysis and results: there are no previous complaints of this code batch.4,740 units of this code batch were manufactured and distributed in the market, there are no units in stock.The ampoule received shows leakage in the transitional area of the tip-cannula and this impedes the product to flow out from the ampoule.Review of the batch manufacturing record of this product was completed, and no abnormalities were found.The product had a normal process and it was released into the market without incidences.Final conclusion: taking into account that the results of sample received do not fulfil oem specifications, it is concluded that the complaint is justified.Corrective/preventive actions: there is no need to establish corrective or preventive actions.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): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5132002
• MDR Text Key: 27801188
• Report Number: 2916714-2015-00871
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: SEENARRATIVE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• 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: 214463N2
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other