MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD Q-SYTE

Catalog Number UNKNOWN

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that unspecified bd¿ q-syte was damaged.The following information was provided by the initial reporter: inspection before use found that the connector has holes.

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.A dhr could not be performed due to the unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that unspecified bd¿ q-syte was damaged.The following information was provided by the initial reporter: inspection before use found that the connector has holes.

• Brand Name: UNSPECIFIED BD Q-SYTE
• Type of Device: Q-SYTE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11084185
• MDR Text Key: 224397008
• Report Number: 2243072-2020-02170
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1