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	Material Frayed (1262); Defective Component (2292)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that powerglide midline 18 gauge 8cm guide wire came off in patient.Patient was sent to nearby hospital emergency room to have imaging to evaluate.Additional info from customer: ((b)(6) 2023).Pt needed to be transferred to er for scans.Discovered after midline placement when needle was pulled out of patient¿s arm and the guide wire was missing.Unknown if it broken in multiple pieces.It was never recovered.Images were taken in er and nothing showed up on images.Patient just received outside referral for further scans and images in her hometown.Patients was already nervous before midline, so the event made it even worse.No other negative outcomes to date.
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 customer that powerglide midline 18 gauge 8cm guide wire came off in patient.Patient was sent to nearby hospital emergency room to have imaging to evaluate.Additional info from customer: (03-aug-2023).Pt needed to be transferred to er for scans.Discovered after midline placement when needle was pulled out of patient¿s arm and the guide wire was missing.Unknown if it broken in multiple pieces.It was never recovered.Images were taken in er and nothing showed up on images.Patient just received outside referral for further scans and images in her hometown.Patients was already nervous before midline, so the event made it even worse.No other negative outcomes to date.
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.Based on a review of this information, the following was concluded: the complaint of a guidewire detachment was not confirmed; however, the guidewire was unable to advance which likely contributed to the perception indicated in the reported event.One 18 ga powerglide pro device was returned for evaluation.The safety mechanism was activated and the catheter was returned fully advanced off the needle.An attempt to advance the guidewire using the purple slider was unsuccessful.The guidewire was found to be present within the housing decoupled from the slider.No evidence of detachment or fraying of the wire was noted.Microscopic inspection of the purple slider revealed material impressions which were indicative of proper assembly of the guidewire.Based on the condition of the returned sample, possible contributing factors include advancement against resistance or into tissue.However, the mechanism which caused the guidewire to become decoupled from the slider remains unknown.This complaint will be recorded for future trending and monitoring purposes.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17493549
• Report Number: 3006260740-2023-03430
• Device Sequence Number: 17953606
• Product Code: FOZ
• UDI-Device Identifier: 00801741215865
• UDI-Public: (01)00801741215865
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: PCK00005
• Device Lot Number: REHQ0256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Race: White