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

Catalog Number UNKNOWN

Device Problem Inaccurate Flow Rate (1249)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd¿ infusion set infused the propofol faster than expected.The following information was provided by the initial reporter: "per my discussion with the rn, the bottle of propofol infused in full, despite what the pump states.He hung the full bottle of propofol and went back in 15 minutes to find the bottle near empty and the patient symptomatic.".

Event Description

It was reported that the unspecified bd¿ infusion set infused the propofol faster than expected.The following information was provided by the initial reporter: "per my discussion with the rn, the bottle of propofol infused in full, despite what the pump states.He hung the full bottle of propofol and went back in 15 minutes to find the bottle near empty and the patient symptomatic.".

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported that a full bottle of propofol was hung and when it was checked 15 minutes later, the bottle was found near empty and the patient symptomatic.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because model and lot numbers were unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.

• Brand Name: UNSPECIFIED BD¿ INFUSION 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: 12920296
• MDR Text Key: 286262780
• Report Number: 2243072-2021-02846
• 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,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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