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

Catalog Number UNKNOWN

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

It was reported that the unspecified bd infusion set experienced the following information was provided by the initial reporter: during clinical configuration call for commercial remediation, the account noted issues with primary infusion flow during secondary infusion administration of paclitaxel.They shared paclitaxel doses were commonly in 500cc+ bags and given as secondary administration.Clinical consultant on the line provided education on dropping primary bag by 2 secondary hooks, to achieve a greater distance between primary and secondary bags.Customer stated they commonly do so, and still experience concurrent flow from primary bags when administering secondary infusions.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.

Event Description

It was reported that the unspecified bd infusion set experienced.The following information was provided by the initial reporter: verbatim: during clinical configuration call for commercial remediation, the account noted issues with primary infusion flow during secondary infusion administration of paclitaxel.They shared paclitaxel doses were commonly in 500cc+ bags and given as secondary administration.Clinical consultant on the line provided education on dropping primary bag by 2 secondary hooks, to achieve a greater distance between primary and secondary bags.Customer stated they commonly do so, and still experience concurrent flow from primary bags when administering secondary infusions.

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported by the customer that they are experiencing concurrent flow from primary bags when administering secondary infusions.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.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16873317
• MDR Text Key: 314910776
• Report Number: 2243072-2023-00743
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• 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
• Date Manufacturer Received: 05/10/2023
• 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