MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD; DEVICE, INTRAVASCULAR, CATHETER SECUREMENT

Catalog Number	DI0120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that patient noted blood and asked that the device be removed.The dressing was saturated with dried sanguineous.A tiny opening through the arterial line was found due to the stat lock placement.The stat lock was unable to be removed as the edge was cutting through the catheter.Patient unable to start dialysis, delayed care.No other information provided, at this time.
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 device has not been returned to the manufacturer for evaluation.

• Brand Name: STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD
• Common Device Name: DEVICE, INTRAVASCULAR, CATHETER SECUREMENT
• 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21068762
• Report Number: 3006260740-2024-08040
• Device Sequence Number: 3493430
• Product Code: KMK
• UDI-Device Identifier: 00801741081637
• UDI-Public: (01)00801741081637(11)231024(17)260828(10)JUHV1832
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: 08/28/2026
• Device Catalogue Number: DI0120
• Device Lot Number: JUHV1832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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