MAUDE Adverse Event Report: BECTON DICKINSON PRI TUBING; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Cardiac Arrest (1762)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of there was a potential issue with the pump and/or tubing as two patients coded after pump alarmed air in line.Could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Rationale: per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.

Event Description

It was reported that the air in line alarm went off while using pri tubing.The following information was provided by the initial reporter: material no.: unknown, batch no.: unknown.It was reported there was a potential issue with the pump and/or tubing as two patients coded after pump alarmed air in line.Verbatim: we had (b)(6) incidents of patients coding recently that made us wonder about a potential issue with the pump and or tubing and i wanted to alert you all to it.Both patient had levophed running, both had ¿air in line¿ alerts.Both patients were so tenuous in the small amount of time it took to address, the patient coded.Neither of the lines had air.It could be totally coincidental as it only has happened with levophed and both patients were extremely ill but the question i¿m curious about is was it a true air in line alert or is there something causing this to go off that isn't air.We took both pumps out of service and biomed is testing them.We also kept the tubing from the second patient as it was seen as a coincidence at that point.Wanted to be sure you were aware and alert your icu teams as you feel necessary.Will be sure to send any updates i get from biomed.

• Brand Name: PRI TUBING
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10584314
• MDR Text Key: 208491218
• Report Number: 2243072-2020-01498
• Device Sequence Number: 1
• Product Code: FPA
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: 08/26/2020
• 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
• Patient Age: 24 YR
• Patient Weight: 53