MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (22G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Ecchymosis (1818); Pain (1994)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer ¿rn & i were seeing a patient today.Powerglide pro examined prior to insertion and found to be fully intact.2 vat rns and bedside rn present for insertion and found that technique was appropriate.Powerglide pro inserted with no difficulty until after deployment of guide wire.Successful guidewire deployment but immediate inability to thread catheter off of the device led to immediate cessation of attempt to thread and attempt was made to retract guidewire without success.Ultimately, procedure was aborted and attempted to pull the line from patient's arm with extreme difficulty and patient reported extreme pain.Line successfully removed from patient and is intact with no residual catheter left in patient.Arm examined under ultrasound, found with no complications to vasculature that was attempted for cannulation.Small area of ecchymosis at site removal.¿ 1/8/2024 ¿ one device was returned for evaluation.The catheter was found broken and the guidewire revealed several misaligned coils on the distal tip.
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 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.Based on a review of this information, the following was concluded: the complaint of the failure of the powerglide pro is confirmed and was determined to be use related.One 22 ga powerglide pro was returned for evaluation.A break in the catheter was observed, and the fracture appeared to be in a chevron shape with a granular fracture surface.Observations of the returned guidewire revealed several misaligned coils on the distal tip inside the distal catheter segment.Abundant blood use residues were observed.The failure appears to be caused by retraction of the catheter and guidewire against the needle bevel; therefore, the complaint of the failure of the device is confirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings in section h:11.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (22G) (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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18628266
• Report Number: 3006260740-2024-00305
• Device Sequence Number: 7791099
• Product Code: FOZ
• UDI-Device Identifier: 00801741142680
• UDI-Public: (01)00801741142680
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: F122080T
• Device Lot Number: REGP3083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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