MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS CRESCENT SLIDING POST; 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	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that statlock sliding post was not moving to enclose the picc line wing during dressing change.Nurse at facility used other fresh statlock and resolve the issue.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 manufacturer has received the sample and will evaluate.Results are expected soon.
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 disconnection of the plastic retainer from the extension tube is confirmed but the root cause could not be identified from the returned photographs.Two photographs of the sliding post statlock stabilization device was returned for evaluation.An initial visual observation of the first returned photograph showed no obvious use residues throughout the statlock device.Nothing remarkable could be observed from the first returned photograph.The second returned photograph showed someone holding the tricot pad of the statlock device back from its plastic retainer.The plastic was disconnected from the white pad of the statlock device.Because the plastic retainer was observed to be detached from its foam pad, the complaint of disconnection is confirmed.Due to the inability to observe the physical sample under a microscope and other unknown clinical conditions, the exact cause of the disconnection could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that statlock sliding post was not moving to enclose the picc line wing during dressing change.Nurse at facility used other fresh statlock and resolve the issue.No other information was provided.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19374902
• Report Number: 3006260740-2024-02538
• Device Sequence Number: 7703357
• Product Code: KMK
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024
• 2 Devices were Involved in the Event: 1 2

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: PIC0220
• Device Lot Number: JUHU0661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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