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

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
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 that the nurse had no difficulty finding the vein and inserting the needle.Once resistance was noted after threading the wire and beginning to advance the catheter over the wire, the nurse immediately attempted to remove the entire device which was the catheter and needle all at once.Much resistance was noted at attempt to remove device, but after more effort was applied, the entire device was removed without any part of the catheter left in the patient.Once removed and examined, the catheter had been sheared by the needle, but did not break off.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 split in the catheter is confirmed and was determined to be use-related.One 20 ga powerglide pro was returned for evaluation.An initial visual observation of the returned device revealed blood use residues throughout the returned device.It was observed that the catheter was still attached to the device.The distal end of the needle shaft was observed to puncture through the distal end of the catheter.A functional test of attempting to advance the guidewire through the needle shaft revealed the guidewire would not advance.A microscopic observation of the needle shaft revealed the guidewire was stuck inside the needle shaft from abundant blood use residues.The distal weld tip of the guidewire was observed to be intact.Pulling back the catheter and guidewire against the needle bevel will cause difficulty during insertion and removal of the device, as the guidewire and catheter may become damaged from the needle bevel.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO, REINFORCED TIP
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21532164
• Report Number: 3006260740-2025-01253
• Device Sequence Number: 8050690
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673(11)240811(17)260131(10)REJU0214
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: F120100T
• Device Lot Number: REJU0214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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