POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN
Report
- Report Number
- 3006260740-2023-05791
- Event Type
- Malfunction
- Date Received
- December 21, 2023
- Date of Event
- November 17, 2023
- Report Date
- March 5, 2024
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- FPA
- UDI-DI
- 00801741047435
- PMA / PMN Number
- K153440
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF A DAMAGED INFUSION SET IS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. TWO PHOTOGRAPHS OF INFUSION SETS WERE RETURNED FOR EVALUATION. ONE PHOTOGRAPH OF THREE 19G X 0.75¿ POWERLOC MAX KITS WAS ALSO RETURNED. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPHS SHOWED THE EXTENSION TUBING WAS BROKEN AT THE JUNCTION BETWEEN THE TUBE AND LUER CONNECTOR. EVIDENCE OF USE WAS OBSERVED ON THE SAMPLE. ALTHOUGH A BREAK IN THE EXTENSION TUBING WAS EVIDENT IN THE SUBMITTED PHOTOGRAPH, INSPECTION OF THE PHOTOGRAPH WAS INSUFFICIENT TO IDENTIFY THE CAUSE OF THE DAMAGE. CONSEQUENTLY, THIS COMPLAINT IS CONFIRMED AS ¿CAUSE UNKNOWN¿ AT THIS TIME. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON.
NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS. ALSO, INQUIRING IF THE MINILOC AND SAFESTEP NEEDLES ARE DEHP FREE. MS&S RESPONSE: INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURE ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH THE MINILOC AND SAFESTEP NEEDLES AND PACKAGING ARE DEHP FREE. CHEMOTHERAPY (BLINATUMOMAB) HAD INFUSED THROUGH THE DEVICE. EVENT DIRECTLY INVOLVED A PATIENT. SINCE THE TUBING WAS CRACKED, THE CHEMOTHERAPY LEAKED OUT OF THE LINE AND ONTO THE PATIENT. NO IMMEDIATE HARM WAS NOTED. THE NURSES HAD TO PROPERLY DISPOSE OF THE CLOTHING AND BEDDING THAT THE CHEMOTHERAPY LEAKED ONTO. THEY HAD TO RE-ACCESS THE PATIENT WITH A NEW NEEDLE AND ASK THE PHARMACY FOR A NEW CHEMOTHERAPY PREPARATION.
NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS. ALSO, INQUIRING IF THE MINILOC AND SAFESTEP NEEDLES ARE DEHP FREE. MS&S RESPONSE: INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURE ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH THE MINILOC AND SAFESTEP NEEDLES AND PACKAGING ARE DEHP FREE. CHEMOTHERAPY (BLINATUMOMAB) HAD INFUSED THROUGH THE DEVICE. EVENT DIRECTLY INVOLVED A PATIENT. SINCE THE TUBING WAS CRACKED, THE CHEMOTHERAPY LEAKED OUT OF THE LINE AND ONTO THE PATIENT. NO IMMEDIATE HARM WAS NOTED. THE NURSES HAD TO PROPERLY DISPOSE OF THE CLOTHING AND BEDDING THAT THE CHEMOTHERAPY LEAKED ONTO. THEY HAD TO RE-ACCESS THE PATIENT WITH A NEW NEEDLE AND ASK THE PHARMACY FOR A NEW CHEMOTHERAPY PREPARATION.
NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS. ALSO, INQUIRING IF THE MINILOC AND SAFESTEP NEEDLES ARE DEHP FREE. MS&S RESPONSE: INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURE ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH THE MINILOC AND SAFESTEP NEEDLES AND PACKAGING ARE DEHP FREE. CHEMOTHERAPY (BLINATUMOMAB) HAD INFUSED THROUGH THE DEVICE. EVENT DIRECTLY INVOLVED A PATIENT. SINCE THE TUBING WAS CRACKED, THE CHEMOTHERAPY LEAKED OUT OF THE LINE AND ONTO THE PATIENT. NO IMMEDIATE HARM WAS NOTED. THE NURSES HAD TO PROPERLY DISPOSE OF THE CLOTHING AND BEDDING THAT THE CHEMOTHERAPY LEAKED ONTO. THEY HAD TO RE-ACCESS THE PATIENT WITH A NEW NEEDLE AND ASK THE PHARMACY FOR A NEW CHEMOTHERAPY PREPARATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2153237 | POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN | SET, ADMINISTRATION, INTRAVASCULAR | FPA | C.R. BARD, INC. (BASD) -3006260740 | N/A | ASGTFC116 | 00801741047435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |