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

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Apnea (1720)

Event Date 03/03/2021

Event Type  Injury  

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.Medical device expiration date: unknown.Reporter address: the customer's address is unknown.(b)(4) usa has been used as a default.The initial reporter also notified the fda on 26 march, 2021.Medwatch report # mw5099919.Report source other: medwatch report.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the patient received an excess dose while using unspecified bd¿ iv set.The following information was provided by the initial reporter: material #: unknown.Batch/ lot #: unknown.It was reported that the 50ml propofol bottle was empty and the patient received an excess dose of propofol leading to apnea.Verbatim: a patient was taken to the operating room for a planned hemorrhoidectomy under sedation.He had received 2mg versed prior to transport.He moved himself to the prone position on the operating room bed.Monitors, nasal cannula oxygen, and a propofol infusion were connected.The infusion was programmed to run at 35 mcg/kg/min.While positioning was continuing, the patient became unresponsive and spo2 dropped.It was then noted that the 50 ml propofol bottle was empty and that the patient had received an excess dose of propofol leading to apnea.Pump used: alaris smart pump investigation: pump was programmed and loaded correctly by the user.No obvious reason apparent for why fluid would free flow.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.It was reported that the 50ml propofol bottle was empty and the patient received an excess dose of propofol leading to apena.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 a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that the patient received an excess dose while using unspecified bd¿ iv set.The following information was provided by the initial reporter: material #: unknown.Batch/ lot #: unknown.It was reported that the 50ml propofol bottle was empty and the patient received an excess dose of propofol leading to apena.Verbatim: a patient was taken to the operating room for a planned hemorrhoidectomy under sedation.He had received 2mg versed prior to transport.He moved himself to the prone position on the operating room bed.Monitors, nasel cannula oxygen and a propofol infusion were connected.The infusion was programmed to run at 35 mcg/kg/min.While positioning was continuing, the patient became unresponsive and spo2 dropped.It was then noted that the 50 ml propofol bottle was empty and that the patient had received an excess dose of propofol leading to apnea.Pump used: alaris smart pump investigation: pump was programmed and loaded correctly by the user.No obvious reason apparent for why fluid would free flow.

• Brand Name: UNSPECIFIED BD IV SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11750599
• MDR Text Key: 263953890
• Report Number: 2243072-2021-01298
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• 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
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other