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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3006260740-2023-05218
• Device Sequence Number: 7015790
• Product Code: FPA
• UDI-Device Identifier: 00801741047411
• UDI-Public: (01)00801741047411
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown