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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Blister (4537)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
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 after placing statlock, patient immediately suffered allergic reaction.No patient injury was reported.No other information was provided.
Event or Problem Description
Additional information received 08-jan-2026: the allergic symptoms began within 24 hours of applying statlock.The affected site was treated with mupirocin ointment and antihistamine.Also, alternative day dressing protocol was followed for 2 weeks.Statlock device was removed and switched to manual suture securement method.Yes, the patient has recovered.
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.
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 skin reaction was confirmed but the cause is unknown two photographs were returned of the implicated picc plus tricot statlock stabilization device.The statlock pad was partially peeled back from the patient by a gloved hand, showing the skin.Skin irritation was seen where the device had been removed.The skin was pinkish red with what appeared to be white purulent discharge.The irritated area appeared to match the footprint of the statlock substrate pad.The adhesive surface of the pad contained yellowish-brown staining throughout.Although damage to the skin was seen at the statlock site, the exact cause could not be determined.It is possible that patient sensitivities or clinical procedures (e.G.Antimicrobial agents not allowed to dry) may have been contributing factors.The product sterilization certificate for this lot was reviewed which showed that the sterilization cycle within the validated parameters.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 sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23995662
• Report Number: 3006260740-2025-10302
• Device Sequence Number: 10523778
• Product Code: KMK
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948(11)250302(17)271228(10)JUKN8654
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUKN8654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 02/04/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/21/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2025
• 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: Required Intervention
• Patient Sex: Unknown