MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE

Catalog Number 306553

Device Problem Disconnection (1171)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.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 10 ml bd posiflush¿ sf saline syringe had a plunger that disconnected when trying to withdraw blood.

Manufacturer Narrative

Correction: describe event or problem: it was reported that a 10 ml bd posiflush¿ sf saline syringe had a plunger that disconnected when trying to withdraw blood.It was reported that this occurred on 10 separate occasions but the date/time and or patient information is unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the investigation, the root cause cannot be determined as posiflush syringes are pre-filled single use syringe intended for flushing.Therefore, the reported plunger disconnected when trying to withdraw blood was due to customer misuse.Prefilled and conventional syringes have different purposes.

Event Description

It was reported that a 10 ml bd posiflush¿ sf saline syringe had a plunger that disconnected when trying to withdraw blood.It was reported that this occurred on 10 separate occasions but the date/time and or patient information is unknown.

• Brand Name: 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8185913
• MDR Text Key: 131176804
• Report Number: 9616657-2018-00075
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

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: Other
• Device Catalogue Number: 306553
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other