MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ NS FILLED SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306546

Device Problems Activation, Positioning or Separation Problem (2906); Improper Flow or Infusion (2954)

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

Event Date 10/31/2018

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 the bd posiflush¿ ns filled syringes were "only allowing about 5ml of the 10ml to be dispensed" due to difficult plunger movement.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Thirteen sample units belonging to lot number 7110587 were received for evaluation by our quality engineer team.Upon visual inspection of the samples, plunger resistance was identified.A device history record review for lot number 7110587 revealed one non-conformance during the production process that may have contributed to this incident.There was a recorded intermittent issue with the hosing in the manufacturing machinery at the time of this lot's production.Product associated with this defect was held for inspection and all affected material should have been rejected to scrap.It is possible that the product reported within this incident went undetected.A correction has been made to the silicone supply hosing machinery within the designated fill room to prevent this issue from reoccurring.Complaints received for this device and defect will be monitored by our quality team for emerging trends.

Event Description

It was reported that the bd posiflush ns filled syringes were "only allowing about 5ml of the 10ml to be dispensed" due to difficult plunger movement.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD POSIFLUSH¿ NS FILLED SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8086106
• MDR Text Key: 128399086
• Report Number: 9616657-2018-00053
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7110587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other