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

Model Number	N/A
Medical Device Problem Codes	Misassembled (1398); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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 as we were placing powerglides today one of them had the safety mechanism broken in it.We checked the wire prior to insertion, and all moved smoothly.Upon inserting the needle and then advancing the catheter into the vein, as the nurse retracted the housing to safety the needle, the plastic piece that is supposed to encompass the needle tip broke into two places and never safetied the needle.The back part of the plastic stayed in the back out the catheter housing.No further details available or provided.
Additional Manufacturer Narrative
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 defective safety mechanism is confirmed and was determined to be related to the manufacture of the device.One 20 ga powerglide pro device was returned for evaluation.An initial visual observation of the returned device showed blood residues throughout the powerglide pro.The outer plastic of the safety mechanism was detached from the inner safety mechanism component and not connected to the device.The inner housing of the safety mechanism was inside the housing of the powerglide pro attached to the needle shaft.A functional test of attempting to slide the inner housing of the safety mechanism down the needle shaft after disassembly of the powerglide pro revealed the safety mechanism moved freely along the needle shaft and was able to slide off the needle shaft.The top component of the safety mechanism was observed to be missing from the device upon the return of the powerglide pro.A microscopic observation revealed no obvious deformation along the safety mechanism inner housing, and no deformation was observed along the outer housing of the safety mechanism.The red ring of the safety mechanism was not broken.This misassembly of the safety mechanism caused the inner section of the safety mechanism to detach from the outer section of the safety mechanism leading to failure of the safety mechanism.This failure was determined to be caused during the manufacture of the device.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: 24059216
• Report Number: 3006260740-2026-00028
• Device Sequence Number: 18610684
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673(11)250617(17)261231(10)REKS1275
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/05/2026

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: REKS1275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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