MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PHASEAL

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 03/05/2019

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Email (b)(6) 2019: "this was an unusual reporting b/c this is not our product, but rather an outside vendor provided this to the patient.The patient reported this to the infusion therapy nurse, so we don¿t have the specific information concerning the lot, etc.In the picture(s) that the patient provided ¿ the top shows where the break occurred adjacent (to the left of the larger hub).The fda has telephoned us specifically about this report b/c of the high risk of a chemotherapy spill in the community.".

Event Description

It was reported that an unknown bd¿ phaseal leaked when the patient stood up, leaking chemo on the patient when they stood.Customer text: the patient was sent home with a twenty-four hour yondelis chemo infusion.The patient shared that approximately twelve hours into the infusion she got up to go to the bathroom.When she stood up, she noticed that her feet were wet.The patient noticed the chemo dripping out of the bag.Patient went to local emergency room, where they cleaned up, managed the spil, and flushed her port.The patient received about 50% of the dose that is given once every three weeks.The patient was unable to complete her therapy, as it is unclear exactly how much drug she got and how much was spilled.This was very disappointing for pt, who had traveled home, which is about one hundred miles from our hospital.The patient reported that the spike broke on enlarging the top picture (the spike is completely broken off hub).Reassurance provided to the patient.The carrier bag was replaced with an extra large carrier bag for use with the next infusion of chemotherapy.We do not have the exact lot number of the faulty phaseal spike.

Manufacturer Narrative

Mdr was submitted in error, this is a duplicate of mfr report # 2243072-2019-00470 / patient identifier (b)(6).

Event Description

It was reported that an unknown bd¿ phaseal leaked when the patient stood up, leaking chemo on the patient when they stood.Customer text: the patient was sent home with a twenty-four hour yondelis chemo infusion.The patient shared that approximately twelve hours into the infusion she got up to go to the bathroom.When she stood up, she noticed that her feet were wet.The patient noticed the chemo dripping out of the bag.Patient went to local emergency room, where they cleaned up, managed the spil, and flushed her port.The patient received about 50% of the dose that is given once every three weeks.The patient was unable to complete her therapy, as it is unclear exactly how much drug she got and how much was spilled.This was very disappointing for pt, who had traveled home, which is about one hundred miles from our hospital.The patiet reported that the spike broke on enlarging the top picture (the spike is completely broken off hub).Reassurance provided to the patient.The carrier bag was replaced with an extra large carrier bag for use with the next infusion of chemotherapy.We do not have the exact lot number of the faulty phaseal spike.

• Brand Name: BD¿ PHASEAL
• Type of Device: PHASEAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8437631
• MDR Text Key: 139367468
• Report Number: 2243072-2019-00528
• Device Sequence Number: 1
• Product Code: LHI
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR