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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that powerglide needle failed to safety.
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 safety mechanism failure was confirmed and the cause was manufacturing related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.The catheter had been advanced and was not returned.The safety cannister remained within the needle housing, leaving the needle tip exposed.Tactile inspection of the safety revealed that it rotated freely on the needle shaft.Initial attempts to advance the safety were unsuccessful, as resistance was encountered.The safety was eventually activated successfully; however, substantial effort was required to overcome the resistance.Microscopic inspection of the needle shaft revealed clear material adhered to the needle shaft within the region of resistance.The material fluoresced under ultraviolet light and appeared consistent with the adhesive used to bond the needle shaft to the plastic retainer.It appeared that adhesive was misapplied on the needle during the manufacturing process.That adhesive resulted in thickening of the needle shaft, which prevented safety mechanism passage when the catheter as advanced.

• 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: kelly m. rackley ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22834185
• Report Number: 3006260740-2025-05926
• Device Sequence Number: 9430912
• Product Code: FOZ
• UDI-Device Identifier: 00801741142758
• UDI-Public: (01)00801741142758((11)250701(17)260731(10)REKS1428
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 10/14/2025

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: F218101T
• Device Lot Number: REKS1428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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