MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 10/24/2023

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 that during infusion of chemotherapy, leakage occurred at the junction of needle and pipe and caused leakage of chemotherapy onto the patient's skin.No other information provided.

Event Description

It was reported that during infusion of chemotherapy, leakage occurred at the junction of needle and pipe and caused leakage of chemotherapy onto the patient's skin.No other information provided.

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 leaking infusion set is confirmed and was determined to be use-related.One 19 ga x 1.0 in.Powerloc infusion set was returned for evaluation.An initial visual observation revealed some use residues throughout the returned infusion set.A functional test of attempting to infuse water into the infusion set using a 12 ml syringe revealed the extension tubing to leak about halfway down the tubing.A microscopic observation revealed a chevron-shaped split in the extension tubing.Striations were observed along the fracture surface, and the fracture edges appeared sharp.The features observed in the split were consistent with sharp instrument damage.Because the device was found to be leaking in the extension tubing, the complaint of a leaking infusion set is confirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18145730
• MDR Text Key: 328242510
• Report Number: 3006260740-2023-05218
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047411
• UDI-Public: (01)00801741047411
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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: 0141910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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