MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 10 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an incident with a powerglide pro rt.The nurse broke the midline off in a patient¿s arm.Stated that she may have sheared the catheter when she told them she advanced the guidewire and then advanced the catheter and hit resistance halfway, so she then pulled the wings back and tried to re-advance and then couldn¿t remove the device.When she was able to pull back on the device with some manipulation and half the catheter came out.The other half of the catheter was in the patient¿s arm.Doctor was called and was able to come and remove the device at bedside.Stated the extra catheter was not in the vein and was in tissue.Customer states that they educated her on why this happened and not re-advancing the catheter.Patient had to have the catheter removed from arm.Additional information received 02/15/2024: it was reported no patient injury.Event resulted in a delay or change of treatment.
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 evaluate.Results are expected soon.
Event or Problem Description
It was reported that there was an incident with a powerglide pro rt.The nurse broke the midline off in a patient¿s arm.Stated that she may have sheared the catheter when she told them she advanced the guidewire and then advanced the catheter and hit resistance halfway, so she then pulled the wings back and tried to re-advance and then couldn¿t remove the device.When she was able to pull back on the device with some manipulation and half the catheter came out.The other half of the catheter was in the patient¿s arm.Doctor was called and was able to come and remove the device at bedside.Stated the extra catheter was not in the vein and was in tissue.Customer states that they educated her on why this happened and not re-advancing the catheter.Patient had to have the catheter removed from arm.Additional information received 02/15/2024: it was reported no patient injury.Event resulted in a delay or change of treatment.
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 break in the catheter is confirmed and was determined to be use related.One 20 ga powerglide pro was returned for evaluation.An initial visual observation showed abundant blood use residues throughout the returned powerglide pro.The safety mechanism was advanced over the tip of the needle.The guidewire was advanced out of the distal end of the needle tip.The distal tip of the guidewire appeared bent.The returned catheter was returned detached from the powerglide pro.The returned catheter was observed to be circumferentially broken about halfway down the catheter shaft.A microscopic observation revealed a chevron-shaped break in the catheter.The catheter fracture surface appeared granular and uneven.Because of the observed characteristics of the break site in the catheter and the advancement into the tissue of the patient described in the event description, the complaint of a broken catheter is confirmed and was determined to be use related and appeared to be caused by contact between the catheter and the introducer needle tip.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: BASIC KIT 20G X 10 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: 18862506
• Report Number: 3006260740-2024-00980
• Device Sequence Number: 15524542
• Product Code: FOZ
• UDI-Device Identifier: 00801741140488
• UDI-Public: (01)00801741140488
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/22/2024

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F120107T
• Device Lot Number: REGS4215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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: Required Intervention
• Patient Sex: Unknown