MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer" guidewire recoiled when he was checking it prior to insertion." additional information received (b)(6) 2023: it was reported by the customer "when i was checking the guidewire before using the midline catheter, i noticed that i could advance the slide, but the guidewire would not advance.Upon further evaluation, it looks like the guidewire recoiled into the device.I had not yet poked the patient, as we were taught to make sure the guidewire is intact even before insertion.The product i was using was the midline catheter kit.".
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 the guidewire not advancing is confirmed but the exact cause remains unknown.Three photo samples of a powerglide pro device were provided for evaluation.The first image depicted a product sticker label indicating lot: regy1413.The second image showed the proximal end of the device housing.The guidewire appeared to be present and decoupled from the purple slider.The third image showed the distal end of the needle.The catheter is not shown and the safety mechanism has been fully activated over the needle.Based on the information provided, possible contributing factors include advancement of the guidewire into tissue or against resistance resulting in decoupling of the guidewire.Since the guidewire was observed to be in a position that would likely not advance, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer" guidewire recoiled when he was checking it prior to insertion." additional information received 04/18/2023: it was reported by the customer "when i was checking the guidewire before using the midline catheter, i noticed that i could advance the slide, but the guidewire would not advance.Upon further evaluation, it looks like the guidewire recoiled into the device.I had not yet poked the patient, as we were taught to make sure the guidewire is intact even before insertion.The product i was using was the midline catheter kit.".

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16869413
• Report Number: 3006260740-2023-01702
• Device Sequence Number: 5421214
• Product Code: FOZ
• UDI-Device Identifier: 00801741142697
• UDI-Public: (01)00801741142697
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F118081T
• Device Lot Number: REGY1413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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