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

Catalog Number UNKNOWN

Device Problem Backflow (1064)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that bd unspecified iv tubing back flowed into the secondary tubing.The following information was provided by the initial reporter: i have received a message today from a chemo suite staff about a potential tubing or phaseal concern (same products as yesterday) issue: ¿ primary non filtered tubing in use (bd infusion set) ; appeared to be functioning well.¿ chemo med prepped on secondary line- programmed on pump to infuse at specified rate ¿ initially working well ¿ medication bag almost empty but policy is to ensure medication infused down secondary tubing line.¿ when attempted to reprogram to infuse the med left in the line ; it was found that despite pump re-programming to allow for the medication to be infused, the primary line fluid was dripping at a fast rate and infusing back up into the secondary line/chemo med bag.¿ solution: rn changed the lines and infused the rest of the medication without issue (only difference is the phaseal product _ injector and connector) were not used on the new set.The staff were unable to recover any of the product packaging and the chemo lines were discarded in the hazardous waste before i could assess if safe to send for testing.

Manufacturer Narrative

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.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.

Manufacturer Narrative

Investigation summary no product or photo was returned by the customer.The customer complaint of flow issues - back flow could not be verified due to the product not being returned for failure investigation.The lot number was not available and therefore it is not possible to perform a device history review.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 bd unspecified iv tubing back flowed into the secondary tubing.The following information was provided by the initial reporter: i have received a message today from a chemo suite staff about a potential tubing or phaseal concern (same products as yesterday) issue: primary non filtered tubing in use (bd infusion set) ; appeared to be functioning well chemo med prepped on secondary line- programmed on pump to infuse at specified rate ¿ initially working well medication bag almost empty but policy is to ensure medication infused down secondary tubing line when attempted to reprogram to infuse the med left in the line ; it was found that despite pump re-programming to allow for the medication to be infused, the primary line fluid was dripping at a fast rate and infusing back up into the secondary line/chemo med bag solution: rn changed the lines and infused the rest of the medication without issue (only difference is the phaseal product _ injector and connector) were not used on the new set.The staff were unable to recover any of the product packaging and the chemo lines were discarded in the hazardous waste before i could assess if safe to send for testing.

• Brand Name: UNSPECIFIED BD IV 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17814714
• MDR Text Key: 324237374
• Report Number: 2243072-2023-01716
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• 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: 10/03/2023
• 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