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

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "statlocks adhering to the 3m bordered dressings, i asked the staff on 5a to report any instances to me so i could investigate where the previous dressing had been done externally." customer may not be using compatible competitor dressing with our statlock dressing took additional 20 minutes to remove dressing and stat lock.The foam became impossible to remove.The only way the rn could do was use alcohol wand.The dressing also seems to be more difficult to remove from the stat lock.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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer the statlock is adhering to the 3m bordered dressing, snapping at the foam wings.Dressing took additional 20 minutes to remove dressing and stat lock.The foam became impossible to remove.The only way the rn could do was use alcohol wand.The dressing also seems to be more difficult to remove from the statlock.
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.
Event or Problem Description
It was reported by the customer the statlock is adhering to the 3m bordered dressing, snapping at the foam wings.Dressing took additional 20 minutes to remove dressing and stat lock.The foam became impossible to remove.The only way the rn could do was use alcohol wand.The dressing also seems to be more difficult to remove from the statlock.
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 difficulty removing a statlock device 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 the statlock partially attached to a patient¿s skin.Both the left and right sides of the pad appear to be torn off and missing.No details of the break sites could be discerned from the returned photograph, and 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.

• Brand Name: STATLOCK PICC PLUS FIXED 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19566840
• Report Number: 3006260740-2024-03144
• Device Sequence Number: 15197271
• Product Code: KMK
• UDI-Device Identifier: 00801741083396
• UDI-Public: (01)00801741083396
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 07/29/2024

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 Expiration Date: 12/28/2025
• Device Model Number: N/A
• Device Catalogue Number: VPPDFPCE
• Device Lot Number: JUHN8669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 07/29/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/26/2024; 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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