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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported that powerglide needle did not safety when removed from the patient.No harm to 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 the safety mechanism not advancing is confirmed and was determined to be related to manufacturing.One 20 ga powerglide pro was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned powerglide pro.It was observed that the catheter and wings were missing from the device.The safety mechanism was observed to be inside the housing of the device.The needle was exposed without the safety mechanism covering the distal needle tip.A functional test of attempting to slide the safety mechanism down the needle shaft after disassembling the powerglide pro revealed the safety mechanism initially stuck to the needle shaft before coming loose and sliding down the needle shaft.The safety mechanism advanced over the distal needle tip as intended after getting the safety mechanism loose from the needle shaft.A microscopic observation of the device revealed excessive adhesive along the needle shaft at the safety mechanism.The needle shaft was visibly thicker at the proximal end of the needle shaft.A uv light was used to reveal the excessive adhesive at the thicker, proximal end of the needle shaft.Excessive adhesive found along the needle shaft was determined to be the root cause of the failure of the safety mechanism not advancing over the needle tip during use.This failure was determined to be related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that powerglide needle did not safety when removed from the patient.No harm to patient.No other information was provided.

• Brand Name: FULL KIT 20G X 10 CM WITH GUARDIVA AND 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19824516
• Report Number: 3006260740-2024-03984
• Device Sequence Number: 12984668
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587(11)240520(17)250531(10)REJQ1258
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/10/2025

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: F120108PT
• Device Lot Number: REJQ1258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: Other
• Patient Sex: Unknown