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 11/29/2023

Event Type  malfunction  

Event Description

It was reported as rn entered room to hang flush on syringe tubing, patient's pants were noted to be wet around diaper area.(unable to quantify the amount.) when rn lifted shirt, a few drops of blood were noted on her abdomen.Port tubing was noted to be cracked above the first port/lumen.Blood was cleaned from skin.Employee notified who discussed situation with attending.Port was deaccessed.Patient taken to hot to shower her body of any potentially spilled chemotherapy on her skin.After shower, port was reaccessed to flush/cap with saline.Will not redose chemotherapy as we cannot quantify how much chemotherapy was infused/lost.

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.

Event Description

It was reported as rn entered room to hang flush on syringe tubing, patient's pants were noted to be wet around diaper area.(unable to quantify the amount.) when rn lifted shirt, a few drops of blood were noted on her abdomen.Port tubing was noted to be cracked above the first port/lumen.Blood was cleaned from skin.Employee notified who discussed situation with attending.Port was deaccessed.Patient taken to hot to shower her body of any potentially spilled chemotherapy on her skin.After shower, port was re-accessed to flush/cap with saline.Will not re-dose chemotherapy as we cannot quantify how much chemotherapy was infused/lost.

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.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18477112
• MDR Text Key: 333091664
• Report Number: 3006260740-2024-00034
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: ASGYFC044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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
• Patient Sex: Female