MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 10/23/2023

Event Type  malfunction  

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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.

Event Description

It was reported by customer there was a leak at the luerlock connector level.A chemotherapy infusion was in progress, gemcitabine, no other drugs were infusing.The nurse tried to change the glow plug, but the flow continued thereafter.The team therefore had to manage a spill of chemotherapy drug on the patient and the needle had to be changed.Fortunately, no impact on the patient's skin.Needle containing 0.9% nacl, problem seen before administration of chemo, no impact on the user.

Event Description

It was reported by customer there was a leak at the luerlock connector level.A chemotherapy infusion was in progress, gemcitabine, no other drugs were infusing.The nurse tried to change the glow plug, but the flow continued thereafter.The team therefore had to manage a spill of chemotherapy drug on the patient and the needle had to be changed.Fortunately, no impact on the patient's skin.Needle containing 0.9% nacl, problem seen before administration of chemo, no impact on the user.

Manufacturer Narrative

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.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set is unconfirmed because the problem could not be reproduced.One 20 ga x 0.75 in.Powerloc max infusion set with y-site was returned for evaluation.An initial visual observation revealed some use residues throughout the returned sample.It was observed that the safety mechanism was engaged upon the return of the infusion set.Needleless injection caps were returned attached to each luer.A functional test of attempting to infuse water into each luer using a 12 ml syringe revealed nothing remarkable as the infusion set did not show any signs of leaking.The safety mechanism was subsequently disengaged to pressurize the infusion set.A functional test of attempting to pressurize the infusion set with water using a 12 ml syringe for each luer revealed the infusion set did not show any signs of leaking.Because the device didn¿t leak during functional testing, the complaint of a leaking infusion set is unconfirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
• Type of Device: 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 UT 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18387841
• MDR Text Key: 331498876
• Report Number: 3006260740-2023-05861
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153440
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0132075
• Device Lot Number: ASGXFC036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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
• Patient Outcome(s): Other