MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH SYRINGE

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: an additional phone # was provided as (b)(4) device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the unspecified bd posiflush syringe experienced a broken/cracked tip cap.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via posiflush pmcf survey that the clinician experienced patient reaction, and damaged syringe tip cap within the past 12 months.

Manufacturer Narrative

H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the unspecified bd posiflush syringe experienced a broken/cracked tip cap.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via posiflush pmcf survey that the clinician experienced patient reaction, and damaged syringe tip cap within the past 12 months.

• Brand Name: UNSPECIFIED BD POSIFLUSH SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11098722
• MDR Text Key: 227071343
• Report Number: 2243072-2020-02214
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K013621
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1