MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/13/2024
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that a midline just infiltrated in the patient arm and the guidewire disintegrated in the patient arm when we were advancing it and it caused a big hematoma on our patient.No other information was 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.
Event or Problem Description
It was reported that the guidewire disintegrated in the patient arm when we were advancing it and it caused a big hematoma on our patient.No other information was 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 break in the guidewire is confirmed and was determined to be use-related.One 18 ga powerglide pro was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned device.It was observed that the catheter was returned attached to the wings of the device with abundant blood use residues throughout the catheter.The safety mechanism was advanced over the needle tip.The guidewire was observed to be advanced out of the needle tip and unraveled.A microscopic observation of the returned catheter revealed a longitudinally aligned split along the catheter.The split was observed to have sharp fracture edges and a granular fracture surface.An observation of the guidewire revealed the distal weld tip was present along the distal end of the guidewire.The core wire was observed to be broken with the proximal end of the core wire break inside the needle shaft.The coil wire remained intact but unraveled due to the break in the core wire.The guidewire may break and cause a split in the catheter when the guidewire and catheter are pulled back against the needle bevel or due to insertion techniques.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20907085
• Report Number: 3006260740-2024-07386
• Device Sequence Number: 15742091
• Product Code: FOZ
• UDI-Device Identifier: 00801741142642
• UDI-Public: (01)00801741142642(11)240806(17)260131(10)REJT0809
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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,Followup
• Report Date (Section B): 03/28/2025

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 Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: F118080T
• Device Lot Number: REJT0809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 03/28/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 12/13/2024; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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