MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that powerglide catheter was inserted with ease into the patients vein.It was 33% catheter to vein ratio and felt no resistance.When she when to pull out the guidewire, it was stuck and would not move.When she tried again gently the catheter broke off at the hub.The pa clamped the line to keep it from migrating and they sent the patient to ir to remove the catheter under fluoroscopy.Patient received a central line.Patient had to have catheter removed under fluoroscopy and had to have a central line inserted.
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 powerglide catheter was inserted with ease into the patients vein.It was 33% catheter to vein ratio and felt no resistance.When she when to pull out the guidewire, it was stuck and would not move.When she tried again gently the catheter broke off at the hub.The pa clamped the line to keep it from migrating and they sent the patient to ir to remove the catheter under fluoroscopy.Patient received a central line.Patient had to have catheter removed under fluoroscopy and had to have a central line inserted.
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 difficulty advancing the catheter is confirmed and was determined to be use related.One 22 ga powerglide pro was returned for evaluation.An initial visual observation revealed abundant use residues, and the catheter was returned broken with a portion of the guidewire broken off.A microscopic observation revealed the proximal segment of the guidewire to have a cone-shaped taper with a granular fracture surface.The distal segment of the returned guidewire appears to have been bent at an angle with a granular fracture surface as if it was pulled against the needle.The distal tip of the needle was observed to have flattening and deformation around the bevel.The proximal segment of the returned catheter segment appeared to have a chevron-shaped break with a granular fracture surface.The distal catheter segment break site appeared to have a similar chevron-shaped break with a granular fracture site.Because of the fracture features observed throughout the catheter, guidewire and needle tip, the complaint of difficulty advancing the guidewire is confirmed and was determined to be related to pulling the guidewire and catheter against the needle bevel.Such damage may occur if insertion is attempted against resistance, followed by retraction against the needle.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: FULL KIT 22G X 8 CM WITH PROBE COVER
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17597136
• Report Number: 3006260740-2023-03621
• Device Sequence Number: 7402645
• Product Code: FOZ
• UDI-Device Identifier: 00801741140648
• UDI-Public: (01)00801741140648
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: F222088PT
• Device Lot Number: REHP2267
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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 Sex: Unknown