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	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that clamp loosens from bandage.No other information was provided.It was reported this occurred with two devices.This report addresses the first 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 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 device has not been returned to the manufacturer for evaluation.
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 statlock detachment from its padding is confirmed and was determined to be manufacturing related.Two statlock stabilization devices were returned for evaluation.An initial visual observation showed some use residues throughout the returned devices.The latches were returned opened on sample 1 while the latches of sample 2 were observed to be closed shut.Sample 1 was observed to have the plastic portion of the statlock still mostly attached to its padding.Sample 2 was observed to have the plastic portion of the statlock device completely removed from its padding and stuck back on the padding with the closed latches facing downward.A tactile evaluation of the adhesive portions of the two statlock devices revealed that the locations of the adhesive were still tacky.A microscopic observation revealed some sections of the statlock devices with missing adhesive.Because the observable adhesive for each device was observed to be tacky due to not curing completely, the complaint of detached statlock from its padding is confirmed and was determined to be manufacturing related.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that clamp loosens from bandage.No other information was provided.It was reported this occurred with two devices.This report addresses the first device.It was reported there was no impact to the patients.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18728145
• Report Number: 3006260740-2024-00652
• Device Sequence Number: 17715226
• Product Code: KMK
• UDI-Device Identifier: 00801741081507
• UDI-Public: (01)00801741081507
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: 01/28/2026
• Device Model Number: N/A
• Device Catalogue Number: CV0220CE
• Device Lot Number: JUHN1422
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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