MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH SF SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Model Number 306553

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

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.(b)(4).

Event Description

It was reported that 6 bd posiflush¿ sf saline syringes had holes in their packaging units.The following information was provided by the initial reporter: "during the inspection qa found holes in the syringe packets".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided lot number 0251351.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this incident, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, the packages were found damaged, as reported by the customer.At this time, a single cause has not been assigned for the identified damage.H3 other text : see h.10.

Event Description

It was reported that 6 bd posiflush¿ sf saline syringes had holes in their packaging units.The following information was provided by the initial reporter: "during the inspection qa found holes in the syringe packets".

• Brand Name: BD POSIFLUSH SF SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 11248866
• MDR Text Key: 232277348
• Report Number: 9616657-2021-00016
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 0251351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1