MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTERVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2021

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.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 unspecified bd intervascular administration set experienced a case of component separation, leakage, and a separate case of an air bubble being in the line.The following information was provided by the initial reporter: patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to.End of tubing had disconnected from phaseal injector.Large bubble was in part of tubing that enters cassette.

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.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 unspecified bd intervascular administration set experienced a case of component separation, leakage, and a separate case of an air bubble being in the line.The following information was provided by the initial reporter: patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to.End of tubing had disconnected from phaseal injector.Large bubble was in part of tubing that enters cassette.

Manufacturer Narrative

H6: investigation: no product or photo was returned by the customer.It was reported that patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to, and a large bubble was part of tubing.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 are unknown.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 intervascular administration set experienced a case of component separation, leakage, and a separate case of an air bubble being in the line.The following information was provided by the initial reporter: patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to.End of tubing had disconnected from phaseal injector.Large bubble was in part of tubing that enters casette.

• Brand Name: UNSPECIFIED BD INTERVASCULAR ADMINISTRATION SET
• Type of Device: INTERVASCULAR 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: 12846471
• MDR Text Key: 285396073
• Report Number: 2243072-2021-02779
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 11/29/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/17/2021
• 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