MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 CATHETER STABILIZATION, PICC/CENTRAL LINE; CATHETER SECUREMENT DEVICE

Model Number	N/A
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by removing the stat lock it is open and the plural drain is free.We change the stat lock, close it and before closing the dressing, about 1 minute after closing the system the stat lock opens under the eyes of the nurse who notifies the hematologist and the pulmonologist.On the radio id we see that the stat lock has been open since the beginning and that the drain is used every day.No patient injury.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 latch that will not remain closed was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 6-8.5fr universal plus statlock.The returned sample was gross visually and microscopically inspected, but not damage to the components was observed.The unit was functionally tested by placing a 10fr catheter in the statlock and attempting to close the latch.The latch was able to be closed and did not open on its own when left alone for a prolonged time.Based on the available evidence, the customer's reported defect could not be confirmed.

• Brand Name: CATHETER STABILIZATION, PICC/CENTRAL LINE
• Common Device Name: CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21927408
• Report Number: 3006260740-2025-02682
• Device Sequence Number: 15724965
• Product Code: KMK
• UDI-Device Identifier: 00801741083488
• UDI-Public: (01)00801741083488(11)230711(17)260428(10)JUHS8548
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2025

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: 04/28/2026
• Device Model Number: N/A
• Device Catalogue Number: VUPD68
• Device Lot Number: JUHS8548
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 07/12/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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