MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that during the healing process of extravascular devices, immediate damage of the statlock input that serves to prevent accidental displacement of vascular access is evidenced, a situation that had never occurred before.No patient harm.No other information was provided.
Additional Manufacturer Narrative
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 a damaged statlock is confirmed; however, the exact cause is unknown.One photograph of a statlock was returned for evaluation.An initial visual observation of the photograph showed a statlock attached to a catheter as well as the patient¿s skin.The right side of the foam pad of the statlock was observed to be torn and a portion of the pad appeared to be missing.The break site of the pad was observed to be uneven, but no details of the fracture surfaces could be discerned from the returned photograph.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It is reported that during the healing process of extravascular devices, immediate damage of the statlock input that serves to prevent accidental displacement of vascular access is evidenced, a situation that had never occurred before.No patient harm.No other information was provided.

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
• 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: 19476820
• Report Number: 3006260740-2024-02839
• Device Sequence Number: 4071865
• Product Code: KMK
• UDI-Device Identifier: 00801741083365
• UDI-Public: (01)00801741083365(11)240105(17)261128(10)JUHY8110
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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 Model Number: N/A
• Device Catalogue Number: VPPCSP
• Device Lot Number: JUHY8110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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