MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM); CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	F120080T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that the power glide catheter had a small pinhole leak at the catheter near the pink hub.No other information provided, at this time.
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 catheter is confirmed and was determined to be use-related.One catheter from a 20 ga powerglide pro was returned for evaluation.An initial visual observation of the returned catheter showed blood use residues throughout the sample.It was observed that extension tubing was returned attached to the luer of the device.A sharp kink was observed just distal of the luer of the device.A functional test of attempting to infuse water into the catheter using a 12 ml syringe revealed a blood occlusion at the proximal end of the catheter.After pressurizing the catheter with water, the blood was removed from the device.A leak was subsequently found during functional testing at the proximal end of the catheter.A microscopic observation revealed a secondary kink in the catheter proximal to the first observed kink.A longitudinal split was observed at the corner of the proximal kink just distal of the luer.The split was observed to have sharp, uneven fracture edges with a granular fracture surface.The split had characteristics of material fatigue, or cyclic kinking and wear of the catheter.An examination of the catheter structure revealed no potential damage/defect related to the manufacture of the product.The damage location suggests that catheter securement, access and maintenance techniques may have contributed to the event.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21021663
• Report Number: 3006260740-2024-07790
• Device Sequence Number: 9087466
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 04/09/2025

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 Catalogue Number: F120080T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 05/01/2025
• 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