MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PHASEAL INJECTOR

Catalog Number UNKNOWN

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 06/12/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.

Event Description

It was reported that unspecified bd¿ injector disconnected.The following information was provided by the initial reporter: it was reported that patient came to atc due to pump problem, it got disconnected per patient.And patient cannot remember what had caused the disconnection - blood return noted on the port and flushes well ns.  verbatim: 1135 patient came to atc due to pump problem, it got disconnected per patient around 10:30 am and pt cannot remember on what had caused the disconnection.Upon assessment, the pump is beeping and the phaseal injector and connector disconnected without the phaseal blue clamp case.Pt.Cannot remember where the blue case clamp went.Pt clamped the lines on the port a cath lumen and the chemo tubing.No blood seen on any of the tubing's.Blood return noted on the port and flushes well ns.The cadd pump is showing total volume 65.3 ml running at 2 ml/hour.11:50 reconnected the phaseal injector and connector after disinfecting it with alcohol running at @ 2ml/hour as pump programming verified and checked by rn at bedside.Patient is scheduled to have the radiation treatment by 1:30 pm today.Informed dr.And okayed to reconnect the chemo and disconnect the chemo after the radiation treatment.1200 requested transporter for patient.1245 called transporter to expedite 1325 pt transported per wheelchair by hospital transporter to the radiation department.

• Brand Name: UNSPECIFIED BD PHASEAL INJECTOR
• Type of Device: INJECTOR
• 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: 12147379
• MDR Text Key: 261915182
• Report Number: 2243072-2021-01845
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• 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: 06/12/2021
• 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 Age: 1 MO