MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number 990687

Device Problem Connection Problem (2900)

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

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 the bd plastipak¿ luer-lok¿ syringe had a "burr" on it that made needle connection difficult.

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe had a "burr" on it that made needle connection difficult.

Manufacturer Narrative

Investigation: a batch history analysis was performed, quality notifications and maintenance records were verified where no records related to failure were found.The sample was analyzed and it was possible to identify a small deformity in the first thread of the luer lock (nozzle of the syringe).This deformity was causing the difficulty of coupling the equipment to the syringe.We evaluated the press and the mold and we found out a gap in the mold rack assembly (device used to extract the nozzle from the syringe).The problem was corrected by replacing the screw which was causing the clearance in the rack assembly according to maintenance order (b)(4).

• Brand Name: BD PLASTIPAK LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8306435
• MDR Text Key: 135354870
• Report Number: 3003916417-2019-00112
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 990687
• Device Lot Number: 8289533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other