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 Codes	Improper or Incorrect Procedure or Method (2017); Activation Problem (4042)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that 22g/8cm ¿ before insertion, checked the guidewire, retracted well.When inserted in patient, advanced guidewire but couldn¿t pull back the system.Seemed to get stuck and with effort, broke the wire and catheter in patient.Had to call ir, came by bedside and took awhile to retrieve thew hole wire and catheter, catheter came out wrinkled.Gave lots of lidocaine on the area¿ additional information received 2/29/2024: it was reported another powerglide was placed in a different vessel, 20g.The catheter appeared to be perforated and detached between the catheter and the junction of the catheter hub.Ir extracted the wire and catheter with forceps.Patient was not harmed otherwise.
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 a guidewire and catheter breaking during insertion using a powerglide pro is confirmed and was determined to be use-related.One 22 ga powerglide pro was returned for evaluation.An initial visual observation showed blood use residues throughout the returned device.The needle of the powerglide pro was bent upon the return of the device with the safety mechanism advanced over the needle tip.A break was observed in the catheter just distal of the molded luer.A microscopic observation revealed the chevron-shaped break in the catheter to have a granular fracture surface with sharp fracture edges.The distal end of the catheter was returned with the device.The observed characteristics of the split are typically caused by pulling the catheter back against the needle bevel during the insertion process.The complaint of a break in the catheter is confirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by customer that 22g/8cm ¿ before insertion, checked the guidewire, retracted well.When inserted in patient, advanced guidewire but couldn¿t pull back the system.Seemed to get stuck and with effort, broke the wire and catheter in patient.Had to call ir, came by bedside and took awhile to retrieve thew hole wire and catheter, catheter came out wrinkled.Gave lots of lidocaine on the area¿ additional information received 2/29/2024: it was reported another powerglide was placed in a different vessel, 20g.The catheter appeared to be perforated and detached between the catheter and the junction of the catheter hub.Ir extracted the wire and catheter with forceps.Patient was not harmed otherwise.

• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18909545
• Report Number: 3006260740-2024-01111
• Device Sequence Number: 6760713
• Product Code: FOZ
• UDI-Device Identifier: 00801741142680
• UDI-Public: (01)00801741142680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/16/2024
• 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; Required Intervention
• Patient Sex: Unknown