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 Hemorrhage/Bleeding (1888)

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported by customer that a patient with implanted port receiving continuous iv fluids.Rn entered room to do hourly iv check and found patient sitting in bed with a small break in iv tubing near cap.Found patient with blood on legs and around tubing with blood backing up into iv tubing.Iv tubing clamped closest to port insertion site, rn wiped tubing with chlorohexadine wipes, deaccessed port, cleaned skin with chlorohexidine bath, sterile access to reaccess port, new iv tubing and fluids hung.

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.

Event Description

It was reported by customer that a patient with implanted port receiving continuous iv fluids.Rn entered room to do hourly iv check and found patient sitting in bed with a small break in iv tubing near cap.Found patient with blood on legs and around tubing with blood backing up into iv tubing.Iv tubing clamped closest to port insertion site, rn wiped tubing with chlorohexadine wipes, deaccessed port, cleaned skin with chlorohexidine bath, sterile access to reaccess port, new iv tubing and fluids hung.Additional information received 01 august 2023: i was the rn who entered the patient¿s room doing my hourly iv/patient safety checks and saw the patient sitting up in his crib with what appeared to be (and was) blood over his legs/chest/crib sheet.His blood was backing up from his implanted port down the tubing and leaking from the port huber needle access tubing.The patient was wearing a onsie with the tubing underneath it but he had unsnapped the bottom of his onsie and the iv tubing was visible with blood coming out of it.It was very clear where the leak was.I cannot remember which iv fluids were infusing at the time but i believe it was post chemotherapy hydration fluids.The impact could have been a patient clabsi infection with an immunocompromised toddler which could be life threatening.It did cause a delay in care as the patient had to be cleaned (with chg wipes), the port had to be deaccessed, then reaccessed with a new huber needle and all new iv tubing and fluids.To the best of my knowledge the patient did not actually acquire a clabsi.

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.

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 split extension tubing was confirmed and the cause is currently under investigation.The product returned for evaluation was one 20 ga powerloc max infusion set.The returned product sample was evaluated and the following observations were made: a tear in the extension tube was seen at the interface of the proximal luer adapter the fracture surfaces of the damage contained striation-like patterns which were indicative of flexural fatigue based failures, which may have been a contributing factor to the extension tubing damage.Repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event; however, it appeared that additional unidentified factors also contributed.The device is a supplied component and the supplier has been notified of this event.

Event Description

It was reported by customer that a patient with implanted port receiving continuous iv fluids.Rn entered room to do hourly iv check and found patient sitting in bed with a small break in iv tubing near cap.Found patient with blood on legs and around tubing with blood backing up into iv tubing.Iv tubing clamped closest to port insertion site, rn wiped tubing with chlorohexidine wipes, deaccessed port, cleaned skin with chlorohexidine bath, sterile access to reaccess port, new iv tubing and fluids hung.Additional information received 01 august 2023: i was the rn who entered the patient¿s room doing my hourly iv/patient safety checks and saw the patient sitting up in his crib with what appeared to be (and was) blood over his legs/chest/crib sheet.His blood was backing up from his implanted port down the tubing and leaking from the port huber needle access tubing.The patient was wearing a onsie with the tubing underneath it but he had unsnapped the bottom of his onsie and the iv tubing was visible with blood coming out of it.It was very clear where the leak was.I cannot remember which iv fluids were infusing at the time but i believe it was post chemotherapy hydration fluids.The impact could have been a patient clabsi infection with an immunocompromised toddler which could be life threatening.It did cause a delay in care as the patient had to be cleaned (with chg wipes), the port had to be deaccessed, then reaccessed with a new huber needle and all new iv tubing and fluids.To the best of my knowledge the patient did not actually acquire a clabsi.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17276082
• MDR Text Key: 318559208
• Report Number: 3006260740-2023-02806
• Device Sequence Number: 1
• Product Code: FPA
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0142075
• Device Lot Number: ASGZFC016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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): Required Intervention; Other
• Patient Age: 1 YR
• Patient Sex: Male