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

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

Patient Problems Embolism (1829); Hemolysis (1886); Foreign Body Embolism (4439)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 blocked on 40 occasions.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via post market survey that there were occurrences of hemolysis (15), flow rate occluded (40) and particulate embolisms (30).

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 unspecified bd¿ q-syte was blocked on 40 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that there were occurrences of hemolysis (15), flow rate occluded (40) and particulate embolisms (30).

• 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: 11357905
• MDR Text Key: 233262614
• Report Number: 2243072-2021-00487
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other