MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; VASCULAR CATHETER FLUSH SYRINGE

Catalog Number 306546

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 11/11/2018

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 a plunger of 10 ml bd posiflush¿ normal saline syringe was difficult to move before use.

Manufacturer Narrative

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 a plunger of bd posiflush normal saline syringe was difficult to move before use.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: VASCULAR CATHETER FLUSH SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8116347
• MDR Text Key: 128886675
• Report Number: 9616657-2018-00060
• 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: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7110587
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other