MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM); CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	F120100T
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that needle didnt feel like it would advance and he had trouble getting guidewire out.Additional information received on 30aug, i do not have an exact date, it was used within the last 2 weeks there was not any harm or impact on the patient.The needle/catheter was removed without difficulty.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
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 guidewire advancement is confirmed but the root cause could not be determined.One 20 ga powerglide pro was returned for evaluation.An initial visual observation showed no obvious use residues throughout the returned sample.It was observed that the safety mechanism was advanced over the needle tip, and the catheter was returned detached from the needle.A functional test of attempting to slide the guidewire back into its housing revealed the guidewire would not pull back into the housing.The device was disassembled to observe the length of the guidewire.A microscopic observation revealed a slight bend at the proximal end of the guidewire and a slight bend along the distal end of the guidewire.The powerglide was subsequently reassembled to attempt guidewire advancement.A functional test of attempting to advance the guidewire revealed the guidewire would only advance occasionally depending on how it passed over a slight bend in the proximal end of the guidewire.It is unknown whether the guidewire bending was caused during use of the device, or before use of the device.Potential causes of guidewire bending in this product may include incorrect insertion angle or inserting the device against resistance.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that needle didnt feel like it would advance and he had trouble getting guidewire out.Additional information received on 30 aug.I do not have an exact date, it was used within the last 2 weeks.There was not any harm or impact on the patient.The needle/catheter was removed without difficulty.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20258537
• Report Number: 3006260740-2024-05310
• Device Sequence Number: 7484911
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673(11)240516(17)251031(10)REJP4044
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 10/31/2025
• Device Catalogue Number: F120100T
• Device Lot Number: REJP4044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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