MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BDF PHASEAL PROTECTOR; SET, I.V. FLUID TRANSFER - PROTECTOR

Model Number P14

Device Problems Material Puncture/Hole (1504); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Numerous incidents of coring and/or shearing of small particles from rubber septa into drug vials upon piercing septa with md phaseal n35 injector.For certain drugs, nearly every vial shows visible particles once punctured by the phaseal injector (paclitaxel, trastuzumab (herceptin), gemcitabine, etoposide, pemetrexmed (altima), olaratumab (lartruvo), cyclophosphamide, docetaxel).Some drugs occasionally (less than 50 percent of vials) show particles (doxorubicin, ifosfamide, fluorouracil, cetuximab, cisplatin, others); other drugs seem unaffected.Each drug shows characteristic particles (vary between drugs in terms of typical particle size and color) - most show small gray particles, some occasionally also show full cores.In 15 days of using bd phaseal, more than 100 incidents of particulate contamination have been documented by one technician.In each case, no visible particles were observed in the drug after the septum was punctured by the phaseal protector alone - particles became apparent only once the septum was subsequently pierced by the phaseal injector.Removing the phaseal protector from affected vials revealed small particles of ribber stuck to the phaseal protector vent needle, and obvious disruption of the integrity of the vial septum (as opposed to a clean puncture, as would be seen with a regular 16 g needle).Notably, in one case, a syringe containing less than 10 ml of paclitaxel with a visible particle (about 0.75 mm in diameter) in it was filtered through a 0.22 micron filter into an excel bag, and the particle was then observed in the excel bag - suggesting that the particulate load may have exceeded the capacity of the filter membrane.Incidents have occurred with phaseal p14, p50, and p55 protectors.Incident reports were sent to bd, but bd has offered no explanation.

• Brand Name: BDF PHASEAL PROTECTOR
• Type of Device: SET, I.V. FLUID TRANSFER - PROTECTOR
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD)
• MDR Report Key: 6479998
• MDR Text Key: 72623385
• Report Number: MW5069002
• Device Sequence Number: 2
• Product Code: LHI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P14
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention