MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
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 by the customer that after placing in pt arm; the line itself was leaking at the skin entrance.Line was in place and working well except for leaking at the site after flushing with saline or pulling back blood.No injury reported.It was reported this occurred with 2 devices.This report addresses the first device.
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 split in the catheter is confirmed, but the root cause could not be determined.One 20 ga powerglide pro catheter with extension tubing attached was returned for evaluation.An initial visual observation of the returned catheter showed blood residues throughout device.A circumferential split was observed just distal to the luer.The catheter was returned attached to extension tubing.A functional test of flushing the catheter with water using a 12 ml syringe revealed a leak just distal of the molded hub.Blood residues were flushed to better observe the split.No obvious blood occlusion was observed during functional testing of the device.Microscopic inspection of the returned catheter shaft showed an ¿l¿ shaped split just distal of the molded hub.One corner of the split was observed to have characteristics of stretching or pulling of the catheter, leading to a split in the catheter.The opposite corner of the split had sharp fracture edges, indicating a separate cause of failure to initiate the split.The root cause of the failure of the catheter shaft could not be determined; however, potential root causes may include contact of the catheter shaft with a needle or sharp instrument, damage to the catheter during insertion procedures, damage to the catheter during the manufacture of the device, or damage caused by other clinical factors.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO
• Common Device Name: MIDLINE CATHETER
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23291563
• Report Number: 3006260740-2025-07708
• Device Sequence Number: 20056196
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673(11)250707(17)270131(10)REKT1423
• 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): 11/19/2025

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 Model Number: N/A
• Device Catalogue Number: F120100T
• Device Lot Number: REKT1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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