MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE; INTERVASCULAR CATHETER

Catalog Number 990628

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913)

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

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd plastipak¿ hypodermic syringe with needle during use malfunctioned as the plunger was reported with resistance.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: the batch record, quality notification and maintenance records were analyzed for catalog 990628, lot number 3147192, and no deviation was found.Without samples or photos it was not possible to determine the root cause.Complaint was not confirmed.Based on no sample/no photo, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failure.00 complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends investigation conclusion: the batch record, quality notification and maintenance record were verified and no deviation was found.Without samples or photos it was not possible determine the root cause.Complaint not confirmed.Root cause description: without samples or photos it was not possible determine the root cause.

• Brand Name: BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7071879
• MDR Text Key: 94209679
• Report Number: 3003916417-2017-00094
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 990628
• Device Lot Number: 3147192
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2013
• 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