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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Free or Unrestricted Flow (2945); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that unspecified bd¿ pmcf-q-syte-extension-set tubing was damaged on 3 occasions, kinked on 80 occasions, had flow issues on 20 occasions, air bubbles on 3 occasions, leaked on 40 occasions, blood backed up on 30 occasions, and the septum unglued on 3 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via survey response the the clinician experienced tubing defective / damaged (3), tubing kinks (80), flow rate occluded (20), air bubbles / air in line (3), leakage (40), blood backs up and/or not completely expelled (30), the septum of the bd q-syte lifts up at the rim or becomes unglued (3).Additional information related to tubing defective / damaged states: "blocked material prior to using it" additional information related to what leaked and from where states: "infusion fluids" "where the extension set connects with the intravenous line".

• Brand Name: UNSPECIFIED BD PMCF-Q-SYTE-EXTENSION-SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11667320
• MDR Text Key: 253147386
• Report Number: 2243072-2021-01116
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1