MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD STATLOCK; CATHETER SECUREMENT DEVICE

Catalog Number	UNKNOWN
Medical Device Problem Codes	Misconnection (1399); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 that there is a problem with the closing mechanism.It does not stay closed, reopens automatically, or if it does close, it does not hold over time and can reopen at any moment.Seems to apply to any size.Most of the time placed under ultrasound guidance.A specific number of affected devices or patients was not provided by the complainant.
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 would not stay closed was confirmed and determined to be supplier related.The products returned for evaluation were one 6-8.5fr universal plus statlock without product information and one 12-14fr statlock for ref: vupd1214 and lot: jujx1566.No defects were identified in the 12-14fr statlock.Given the lack of relation of the 12-14fr to any reported event, receipt of the device will be documented in this investigation, but the rest of the investigation will be conducted on the 6-8.5fr statlock only.A gross visual inspection of the 6-8.5fr universal plus statlock was unremarkable.The unit was functionally tested by attempting to close the latch.The latch was able to be closed.However, any slight movement of the retainer would cause the latch to release from the catch on its own.Microscopic inspection at the interface between the latch tabs and the catch found that the latch tabs would not fully advance into the catch when the latch was in the closed position.The latch tabs were measured and found to be within specification.The distance from the silicone bump pad to the edge of the retainer was measured and found to be too large.A larger distance in this area would cause the door of the retainer to sit further away from the catch when closed, preventing the latch tabs from fully advancing into the catch.The features observed indicated that the retainer was incorrectly molded during product manufacture.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: BARD STATLOCK
• 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: 24384370
• Report Number: 3006260740-2026-00952
• Device Sequence Number: 10257629
• Product Code: KMK
• UDI-Device Identifier: 00801741083426
• UDI-Public: (01)00801741083426(11)241124(17)270928(10)JUJX0720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• 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): 04/20/2026

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2024
• 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