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

Catalog Number	F120100T
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Infuse (2340); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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 it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that the iv team called by primary rn to place iv on patient.Attempted to placed 20g 10cm powerglide (lot rejz0320).Was able to cannulate vessel without issue and deploy guidewire without resistance.This nurse was able to deploy catheter and was able to hub the device against the patient's skin.Next, when withdrawing needle and guidewire from catheter, i met a great deal of resistance.This nurse stopped and immediately removed the entire apparatus from the patient's arm.Guidewire present and catheter intact.This nurse visually confirmed presence of purple catheter tip.Once device was removed from patient, this nurse pulled the catheter from the needle/guidewire apparatus.I was able to deploy the safety device at that time.After i had the two pieces apart, i attempted to flush the iv catheter, very little flow, not consistent with expected flow through a 20g catheter was noted.Primary nurse notified of same.We are not aware of any harm caused to the patient as a result of this event.No further information 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.
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 difficult catheter insertion causing difficult infusion is confirmed and was determined to be use-related.One 20 ga x 10 cm powerglide pro was returned for evaluation.An initial visual observation of the returned powerglide pro revealed blood use residues throughout the returned catheter and powerglide assembly.The distal tip of the catheter appeared deformed.The distal guidewire observed to be coming out of the needle tip was observed to have a slight curve.The safety mechanism was advanced over the needle tip.A microscopic observation of the guidewire revealed no observable disjointed coils.The distal weld tip was present along the device.Nothing remarkable was observed along the guidewire or the needle.The distal end of the catheter was observed to be stuck together and deformed.This failure may be caused by movement of the catheter against biological components such as a vessel during insertion.Biological residues were observed to have closed the distal end of the catheter together.Inspection of the returned device revealed no damage/defect related to the manufacture of the returned product.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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21943516
• Report Number: 3006260740-2025-02760
• Device Sequence Number: 8534844
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673(11)250208(17)260831(10)REJZ0320
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 08/31/2026
• Device Catalogue Number: F120100T
• Device Lot Number: REJZ0320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 07/01/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/04/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2025
• 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