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

Catalog Number UNKNOWN

Device Problems Break (1069); Complete Blockage (1094); Inability to Irrigate (1337); Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Chemical or Other Material (2944); Free or Unrestricted Flow (2945); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/16/2021

Event Type  Injury  

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 caused clinician to experience an infection on 50 occasions and sepsis on 30 occasions, the tubing was damaged, the tubing was kinked on 131 occasions, had flow issues on 119 occasions, air bubbles on 25 occasions, leaked on 15 occasions, blood backed up on 55 occasions, crystalization on 45 occasions, attachment issues on 15 occasions, hemolysis on 5 occasions, damaged q-syte on 8 occasions, and faulty screw on 30 occasions.The following information was provided by the initial reporter: material no: unknown; batch no: unknown.It was reported via survey response the clinician experienced bloodstream infection or sepsis (30), localised infection (50), tubing defective / damaged (1), tubing kinks (131), flow rate slow (67), flow rate occluded (42), air bubbles / air in line (25), leakage (15), blood backs up and/or not completely expelled (55), crystallization (45), bd q-syte extension set cannot be attached to iso compliant mating device (12), iso compliant device cannot be connected to the bd q-syte septum (3), hemolysis (5), bd q-syte needle-free connector is damaged / defective (8), faulty screw (30).Additional information related to damaged/defective tubing states: "tube was completely bent and liquid wouldn't flow through it".Additional information related to what leaked and from where states: "blood or fluid.From the connectors".Additional information related to damaged/defective needle free connector states: "no seized screw" "connector cap impossible to unscrew" additional information related to bloodstream infection or sepsis states: "sepsis, fever, shivering".Additional information related to localised infection states: "local pain".Additional information related to flow rate slow states: "patient relieved less quickly because flow was slowed down" additional information related to flow rate occluded states: "patient not relieved because the treatment didn't flow".Additional information related to air bubbles / air in line states: "have to drain everything and change the system, which involves increased monitoring of the clinician and increased anxiety for the patient".Additional information related to blood backs up and/or not completely expelled states: "catheter blocked".

• 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: 11667136
• MDR Text Key: 262512671
• Report Number: 2243072-2021-01112
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/08/2021

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?: 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
• 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
• Patient Outcome(s): Other