MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL PAD; DEVICE, INTRAVASCULAR, CATHETER SECUREMENT

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	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the slug buckle opens and buckles separates.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 device has not been received by the manufacturer for evaluation.
Event or Problem Description
It was reported the slug buckle opens and buckles separates.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 detached retainer was confirmed and was determined to be manufacturing related.The product returned for evaluation was a statlock stabilization device.Also received was a lerna pad, a pigtail foam pad, and two foam strips.The plastic retainer was completely detached from the pad.Microscopic inspection of the back of the retainer did not reveal any evidence of adhesive residue.The detached retainer likely occurred due to inadequate adhesive coverage and/or improper primer application.

• Brand Name: STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20047643
• Report Number: 3006260740-2024-04662
• Device Sequence Number: 18126068
• Product Code: KMK
• UDI-Device Identifier: 00801741081507
• UDI-Public: (01)00801741081507(11)230520(17)260428(10)JUHS8506
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: CV0220CE
• Device Lot Number: JUHS8506
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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