MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 20ML S/SU

Catalog Number 990173

Device Problem Material Separation (1562)

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

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ syringe plastipak 20ml s/su stopper separated from the plunger when the medication was aspirated.This occurred on 3 separate occasions but the date/time and or patient information is unknown.No serious injury or medical intervention was reported.

Event Description

It was reported that bd¿ syringe plastipak 20ml s/su stopper separated from the plunger when the medication was aspirated.This occurred on 3 separate occasions but the date/time and or patient information is unknown.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation: a dhr, maintenance record analysis and quality notification analysis were performed and no deviation was found for this batch.No samples / photos were sent by the customer making performing an investigation and determining the root cause for the incident impossible.The manufacturing process are validated with defined acceptance criteria.From these information¿s it is not possible confirm the complaint.

• Brand Name: BD SYRINGE PLASTIPAK 20ML S/SU
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8257492
• MDR Text Key: 133523916
• Report Number: 3003916417-2019-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 990173
• Device Lot Number: 8198718
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other