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	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stabilization device broken off adhesive, allowed the chest tube to move 1-1.5 inches in patient.There was minimal harm.
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.
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 retainer disconnecting from the pad was confirmed but the root cause could not be determined.The products returned for evaluation were two 14-16 fr universal plus statlock devices.One device was returned in an opened state (unit 01) and the other sealed (unit 02).Inspection and testing of unit 02 did not identify any remarkable features and therefore was unconfirmed.The rest of the investigation will focus on unit 01.A gross visual inspection of unit 01 found that the retainer had separated from the retainer pad.The pad was not returned.Adhesive residues were observed on the back of the retainer, suggesting that the retainer had at some point been adhered to the pad.Microscopic inspection of the adhesive found that large gaps were present between segments of adhesive.Additionally, the adhesive did not have a clear pattern transfer from the pad, in comparison to the pattern seen in unit 02.These features potentially suggested that insufficient adhesive may have been applied to the retainer; however, it is possible that some of the adhesive remained on the pad.As the pad was not returned, no further conclusions could be drawn and no specific root cause could be determined.Therefore, the root cause remains unknown.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: 23758392
• Report Number: 3006260740-2025-09438
• Device Sequence Number: 13281727
• Product Code: KMK
• UDI-Device Identifier: 00801741083464
• UDI-Public: (01)00801741083464(11)230902(17)260728(10)JUHV8510
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• 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): 02/12/2026

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 Expiration Date: 07/28/2026
• Device Model Number: N/A
• Device Catalogue Number: VUPD1416
• Device Lot Number: JUHV8510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2023
• 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