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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/11/2024
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 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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported the enclosed guidewire was bent/curved on extending prior to advancing the catheter.One patient was complaining of discomfort with the devise after extending the guide wire and started to advance the catheter.The patient was unharmed and had no discomfort after removal of the devise.No other information was provided.It was reported this occurred with two devices.This report addresses the first device.
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 is confirmed and was determined to be use-related.One 20 ga powerglide pro was returned for evaluation.One photograph of a powerglide pro was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned powerglide pro.The catheter was observed to be attached to the powerglide pro device.The catheter was observed have a split along the catheter shaft causing the distal half of the catheter to be misaligned from the needle.The guidewire was observed to be within the powerglide pro and not advanced.The returned photograph showed the powerglide pro catheter to be coming off the needle at what appeared to be a split site.The guidewire in the returned photograph was observed to be bent parallel to the needle shaft and stuck to the catheter.Abundant blood use residues were observed throughout the device in the returned photograph.A microscopic observation revealed the catheter appeared to have a chevron shaped split with sharp fracture edges.The guidewire was observed to have a sharp bend about halfway down the guidewire during a successful attempt at advancing the guidewire.The guidewire appeared to be intact and the weld tip was present along the device.The characteristics of the bent guidewire and the split in the catheter appear to be caused by pulling the guidewire against the needle bevel of the powerglide pro during attempted use of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported the enclosed guidewire was bent/curved on extending prior to advancing the catheter.One patient was complaining of discomfort with the devise after extending the guide wire and started to advance the catheter.The patient was unharmed and had no discomfort after removal of the devise.No other information was provided.It was reported this occurred with two devices.This report addresses the first device.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19281945
• Report Number: 3006260740-2024-02271
• Device Sequence Number: 18040459
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/26/2024

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F120100T
• Device Lot Number: REHX1914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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