MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 18G X 8 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an 18g 8cm powerglide in for 9 days.It was leaking quite a bit, so they decided to remove it.Once they removed it, they saw that the hub was separated from the catheter.Ir had to remove the catheter from the patient.No other information was provided.
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 will be evaluated.A supplemental will be submitted with evaluation results.
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.
Event or Problem Description
It was reported that the patient had an 18g 8cm powerglide in for 9 days.It was leaking quite a bit, so they decided to remove it.Once they removed it, they saw that the hub was separated from the catheter.Ir had to remove the catheter from the patient.No other information was provided.
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 catheter break is confirmed; however, the exact cause is unknown.One photograph and one radiographic image of a powerglide pro were returned for evaluation.An initial visual observation of the photograph showed a break in the catheter shaft of a powerglide pro device.No details of the break site could be discerned from the returned photograph.Evidence of use as well as biological residue was observed on the sample in the returned photograph.An initial visual observation of the radiographic image showed what appears to be the distal portion of the catheter inside a patient¿s arm.Although a fracture is observed, no details or distinguishing features of the damage can be discerned from the returned images which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that the patient had an 18g 8cm powerglide in for 9 days.It was leaking quite a bit, so they decided to remove it.Once they removed it, they saw that the hub was separated from the catheter.Ir had to remove the catheter from the patient.No other information was provided.

• Brand Name: BASIC KIT 18G X 8 CM WITH GUARDIVA
• 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: 20297992
• Report Number: 3006260740-2024-05461
• Device Sequence Number: 18359504
• Product Code: FOZ
• UDI-Device Identifier: 00801741140457
• UDI-Public: (01)00801741140457(11)240410(17)250831(10)REJP1922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/04/2025

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F118087T
• Device Lot Number: REJP1922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/28/2024; 02/04/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/07/2024; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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