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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Infusion or Flow Problem (2964)

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908)

Event Date 05/21/2021

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 the initial reporter also notified the fda on 10 june, 2021.Medwatch report # mw5101645.Report source other: medwatch report.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of flow issues - accuracy - over infusion/component damage - no leak 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 unspecified bd¿ tubing had flow issues and a broken bezel causing an overdose.The following information was provided by the initial reporter: it was reported by the customer that there is a medication overdose due to broken bezel which allows for the medication to free flow.Verbatim: equipment malfunction the hc-8032b alar is infuser led to medication overdose.Found that there is a broken bezel membrane frame assembly part# tc10006587 this broken piece can allow for the door to be closed and iv fluids to free flow recall alert received in june 2020 with pm performed on this device spt 2020 without any issues pump has been sequestered and is being sent to manufacturer during procedure, anesthesiologist discovered a pump malfunction during the phenylephrine infusion which was running free flow immediate response and treatment to bp increase with successful response in patient condition procedure continued with stable bp.At the completion of the case after the drapes were removed,the patient's left eye appeared dilated and fixed, patient went into cardiac arrest a code was called, and cpr was initiated successful rosc and patient was transferred to icu in critical condition fda safety report id# (b)(4).

• Brand Name: UNSPECIFIED BD 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12200281
• MDR Text Key: 265825958
• Report Number: 2243072-2021-01928
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• 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 Outcome(s): Other