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

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abrasion (1689); Local Reaction (2035); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "4-year old female patient in picc program outpatient clinic is a carrier of catheter picc 4 fr bilumen in right arm with date of insertion of (b)(6) 2024, comes in follow up and healing of the catheter by the external consultation, today consults for presenting sensation of itching, the girl scratches; according to comments of caregiver (grandmother) is observed device covered with transparent dressing with great moisture, irritated skin, and displaced device 10 cm.With a clean technique she removed the transparent dressing and observed marsi with loss of skin integrity, so the catheter was removed.It should be noted that in healing performed on (b)(6) 2024, skin target lesion was observed at the level of the stabilizer, is covered with gauze trying to isolate the affected skin of the stabilizer adhesive to mitigate the progression of the injury.Removal of catheter and impatient to schedule new picc catheter insertion.There was no difficulty removing the catheter and no damage/defect found on the catheter.".
Additional Manufacturer Narrative
The manufacturer has received the sample and it 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 reaction is confirmed; however, the exact cause is unknown.Two photographs of a patient¿s catheter insertion site were returned for evaluation.An initial visual observation of the first photograph showed a powerpicc sv catheter inserted into a patient.The insertion site and surrounding skin did not appear to be irritated.No damage to the catheter could be discerned from the returned photograph.The second photograph showed the device removed from the patient.The insertion site and surrounding skin were observed to be irritated and damaged.From the returned photograph, redness and irritation of the skin could be confirmed; however, the root cause of this reaction could not be determined from the returned photograph.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer "4-year old female patient in picc program outpatient clinic is a carrier of catheter picc 4 fr bilumen in right arm with date of insertion of (b)(6) 2024, comes in follow up and healing of the catheter by the external consultation, today consults for presenting sensation of itching, the girl scratches; according to comments of caregiver (grandmother) is observed device covered with transparent dressing with great moisture, irritated skin, and displaced device 10 cm.With a clean technique she removed the transparent dressing and observed marsi with loss of skin integrity, so the catheter was removed.It should be noted that in healing performed on (b)(6) 2024, skin target lesion was observed at the level of the stabilizer, is covered with gauze trying to isolate the affected skin of the stabilizer adhesive to mitigate the progression of the injury.Removal of catheter and impatient to schedule new picc catheter insertion.There was no difficulty removing the catheter and no damage/defect found on the catheter.".

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20256413
• Report Number: 3006260740-2024-05286
• Device Sequence Number: 7564565
• Product Code: KMK
• UDI-Device Identifier: 00801741083365
• UDI-Public: (01)00801741083365(11)240310(17)270128(10)JUJN8127
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2025

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: JUJN8127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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 Age: 4 YR
• Patient Sex: Female