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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported during the care routine, it was observed that the stat lock detached from the fixation adhesive, resulting in the catheter exteriorization.The dressing was well positioned, with an intact dressing, with no signs of traction or moisture.On (b)(6) 2025, the stat lock and dressing were changed.On (b)(6) 2025 the dressing was intact, dry and well fixed, but the part of the stat lock that accommodates the catheter detached from the adhesive fixation and pulled the catheter, resulting in the loss of the device.
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 the detachment of the retainer of the statlock stabilization device is confirmed, but the root cause could not be determined.Four photographs of a 5 fr t/l catheter and a statlock were returned for evaluation an initial visual observation of the photographs showed the catheter inserted into the patient with a statlock stabilization device and a tegaderm peeled back from the statlock stabilization device.The four photographs showed the plastic retainer of the statlock stabilization device was detached from the pad.The plastic retainer was observed to be attached to the molded joint of the catheter.The pad of the statlock device was observed to be attached to the arm of the patient.It could not be determined from the photographs whether there was adequate adhesive on the plastic retainer of the statlock device.There were no distinguishing features in the photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.

• 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: 23417734
• Report Number: 3006260740-2025-08134
• Device Sequence Number: 13007590
• Product Code: KMK
• UDI-Device Identifier: 00801741083365
• UDI-Public: (01)00801741083365
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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 Model Number: N/A
• Device Catalogue Number: VPPCSP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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