MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported via ms&s "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." this report addresses the safestep needle.
Event or Problem Description
It was reported via ms&s "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." additional information received 12/12/2023: it was reported by the customer chemotherapy (blinatumomab) was infusing through.Since the tubing cracked, chemotherapy leaked out of the line and onto the patient.Nurse 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.
Additional Manufacturer Narrative
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 is pending evaluation.Results are expected soon.
Additional Manufacturer Narrative
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.One photograph of an infusion set was returned for evaluation.An initial visual observation of the photograph showed the extension tubing was broken at the junction between the tube and luer connector.Biological residue was observed on the sample near the break site in the returned photograph.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 h11.
Event or Problem Description
It was reported via ms&s "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." additional information received (b)(6) 2023: it was reported by the customer chemotherapy (blinatumomab) was infusing through.Since the tubing cracked, chemotherapy leaked out of the line and onto the patient.Nurse 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.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18293410
• Report Number: 3006260740-2023-05601
• Device Sequence Number: 6037368
• Product Code: FPA
• UDI-Device Identifier: 00801741047435
• UDI-Public: (01)00801741047435
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2025
• Device Model Number: N/A
• Device Catalogue Number: 0141975
• Device Lot Number: ASGXFC046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 03/04/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/10/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown