MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD Q-SYTE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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 6 unspecified bd q-syte¿ devices had issues with blood exposure, and 20 devices were damaged/defective.The following information was provided by the initial reporter: "it was reported via post market survey that there were occurrences of clinician exposure to blood (6), and devices being damaged / defective (20)." "ruined rubbers.Rubbers which get ruined one day after their usage".

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no material number, 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 6 unspecified bd q-syte¿ devices had issues with blood exposure, and 20 devices were damaged/defective.The following information was provided by the initial reporter: "it was reported via post market survey that there were occurrences of clinician exposure to blood (6), and devices being damaged / defective (20)."."ruined rubbers.Rubbers which get ruined one day after their usage".

• Brand Name: UNSPECIFIED BD Q-SYTE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11345712
• MDR Text Key: 233302441
• Report Number: 2243072-2021-00360
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1