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

Model Number	N/A
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that the statlock devices have sharp edges on the plastic wings.This is creating holes in the central venous line dressings.No harm to patient as of now.Rough edges are causing us to have to change dressings more frequently.A specific number of affected devices or patients was not provided by the complainant.
Event or Problem Description
(b)(6) 2026: it was initially reported that there were "several statlocks" with sharp edges.As a specific number was not provided, the occurrence number defaulted to 1.Five total samples were returned with two showing the reported characteristic.Therefore, the occurrence in the file was updated to 2.
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 defective statlocks is confirmed and was determined to be supplier manufacturing related.Five tricot statlock picc plus devices were returned for evaluation.An initial visual observation revealed three of the statlock devices were returned with their respective packaging and a note stating, "no issues".No obvious damage or defect was observed on these samples.The remaining two statlocks were returned with their retainer tabs closed and within their original packaging.A note was returned with these samples stating "circle visible & palpable at wings".A tactile evaluation was performed, and the two samples were noted to have a slight protuberance on the tab.The protuberances were observed to be slightly sharp.A microscopic observation revealed the protuberances appeared to be made of the same material as the retainer, suggesting it was likely caused by a molding flaw during the manufacturing process.The statlock retainer was a supplied component; however, a supplier notification cannot be created as the retainer is now manufactured at a bd facility.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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23934503
• Report Number: 3006260740-2025-10130
• Device Sequence Number: 17545710
• Product Code: KMK
• UDI-Device Identifier: 00801741082962
• UDI-Public: (01)00801741082962(11)251026(17)280928(10)JUKW0259
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/04/2026

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: PIC0222
• Device Lot Number: JUKW0259
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2025
• 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: Other
• Patient Sex: Unknown