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 09/18/2023

Event Type  malfunction  

Event Description

It was reported by customer that patient arrives in infusion center for pump disconnect.On inspection of chest meniscal amount of white powdery chest, claves all on tight, no leaking visible on the line when flushing.Small crack must be present somewhere in the line but unable to visualize.Skin cleansed and patient discharged.Additional info from customer: ((b)(6) 2023).This situation involved a hazardous drug spill that was discovered through leaking.The hazardous drugs were spilled on area, and patient.When the catheter broke, there was leaking but no piece broken off.

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 received by the manufacturer for evaluation.H3 other text : device not returned.

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.

Event Description

It was reported by customer that patient arrives in infusion center for pump disconnect.On inspection of chest meniscal amount of white powdery chest, claves all on tight, no leaking visible on the line when flushing.Small crack must be present somewhere in the line but unable to visualize.Skin cleansed and patient discharged.Additional info from customer: on 25-sep-2023: this situation involved a hazardous drug spill that was discovered through leaking.The hazardous drugs were spilled on area, and patient.When the catheter broke, there was leaking but no piece broken off.

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.

Event Description

It was reported by customer that patient arrives in infusion center for pump disconnect.On inspection of chest meniscal amount of white powdery chest, claves all on tight, no leaking visible on the line when flushing.Small crack must be present somewhere in the line but unable to visualize.Skin cleansed and patient discharged.Additional info from customer: ((b)(6) 2023) this situation involved a hazardous drug spill that was discovered through leaking.The hazardous drugs were spilled on area, and patient.When the catheter broke, there was leaking but no piece broken off.

• 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 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17866156
• MDR Text Key: 324884857
• Report Number: 3006260740-2023-04457
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0132075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 01/08/2024; 01/23/2024
• Supplement Dates FDA Received: 01/19/2024; 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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