MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II 10 ML SYRINGE; PISTON SYRINGE

Catalog Number 309110

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

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 when trying to aspirate air bubbles form with a bd discardit¿ ii 10 ml syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: when checking for backflow on a piccline, when "to aspirate", air appears in the syringe at the plunger.

Manufacturer Narrative

H.6.Investigation: bd has not been provided with photos or samples for catalog 309110 lot 1910156 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.The device history review showed no indication of the alleged defect.

Event Description

It was reported that when trying to aspirate air bubbles form with a bd discardit¿ ii 10 ml syringe.The following information was provided by the initial reporter, translated from french to english: when checking for backflow on a piccline, when "to aspirate", air appears in the syringe at the plunger.

• Brand Name: BD DISCARDIT II 10 ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9733008
• MDR Text Key: 193097318
• Report Number: 3002682307-2020-00058
• 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: 03/23/2020

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: Other
• Device Catalogue Number: 309110
• Device Lot Number: 1910156
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other