MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK; 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	08/18/2025
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.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.The complaint of difficulty closing the statlock devices is confirmed, but the root cause could not be determined.Two statlock universal plus stabilization devices were returned for evaluation.An initial visual observation of the returned statlock devices revealed no obvious use residues along sample 1, and little use residues along sample 2.A functional test of attempting to close a dialysis catheter into each statlock device revealed the statlock latch would pop open for each device.A functional test of attempting to open and close the latch of each returned device without a catheter in place revealed the devices would close appropriately without a catheter in place.A microscopic observation revealed nothing remarkable along each of the devices nor each of the device¿s latches.The cause of the latches reopening with catheters in place is unknown at this time.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported stat lock catheters and the claps are not working.The customer has to go through 2-3 of before she can get one to work.No further information was provided.It was reported this occurred with eight devices.This report addresses all eight devices.10/28/2025: it was found during an investigation there was difficulty keeping the latches closed.

• Brand Name: 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23450567
• Report Number: 3006260740-2025-08284
• Device Sequence Number: 7968904
• Product Code: KMK
• UDI-Device Identifier: 00801741083440
• UDI-Public: (01)00801741083440(11)231108(17)260928(10)JUHX0249
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: 09/28/2026
• Device Model Number: N/A
• Device Catalogue Number: VUPD1214
• Device Lot Number: JUHX0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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