MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ TUBING; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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: no product or photo was returned by the customer.The customer complaint of flow issues 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 or 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.

Event Description

It was reported that there was overinfusion while using unspecified bd¿ tubing.The following information was provided by the initial reporter: excess flow or over-infusion.

• Brand Name: UNSPECIFIED BD¿ TUBING
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12330482
• MDR Text Key: 266860136
• Report Number: 2243072-2021-02081
• 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
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/17/2021
• 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