MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PICC, INTRODUCERS (STAND ALONE KITS)

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	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that green safety has fallen off of the secure-loc needle in the picc kit.No patient or employee harm.
Additional Manufacturer Narrative
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 it 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.The complaint of safety mechanism failure was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 21ga secureloc safety introducer needle.The sample was received with the safety mechanism activated, fully enclosing the needle tip.The safety mechanism was disassembled and the metal binding clip was measured using a digital microscope and found to be within manufacturing specifications.Following disassembly, the safety mechanism was reset.Subsequent activation of the safety was successful and unremarkable.The safety mechanism functioned as intended and the componentry was found to be within manufacturing specifications.Consequently, this complaint is unconfirmed at this time.

• Brand Name: PICC, INTRODUCERS (STAND ALONE KITS)
• Common Device Name: PICC, INTRODUCERS (STAND ALONE KITS)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21389368
• Report Number: 3006260740-2025-00704
• Device Sequence Number: 8705234
• Product Code: DYB
• UDI-Device Identifier: 00801741041822
• UDI-Public: (01)00801741041822(11)231003(17)260731(10)REHV3475
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050023
• 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): 04/30/2025

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: S03421-275W
• Device Lot Number: REHV3475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: Other
• Patient Sex: Unknown