MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 CATHETER STABILIZATION, PICC/CENTRAL LINE; CATHETER SECUREMENT DEVICE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Local Reaction (2035); Blister (4537)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, patient has developed a red rash that has little blister that leak yellow fluid and is itchy under the area of the statlock.Patient has a known allergy to adhesives.Patient went to er where it was removed and placed on opposite arm, had to stich the line due to allergic reaction to the statlock covered with hypoallergenic dressing.Got infection in picc line has appointment with cardiologist tues (b)(6) 205 for follow up.Picc line was removed.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
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 patient, she is currently using a statlock and has developed a red rash that has little blister that leaks yellow fluid and is itchy under the area of the statlock.She states she has a known allergy to adhesives.
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 that the statlock caused a red rash with little blisters that leak yellow fluid and is itchy under the area of the statlock.The picc became infected.The patient went to the er to have the picc removed and a new catheter placed in the opposite harm.New catheter was stitched in place and a hypoallergenic dressing applied.Patient referred to cardiology for follow up.Additional information received 7/30/2025: patient confirmed the original picc was covered with a tegaderm dressing.Patient could not confirm if blood cultures or culture of the picc was done.Patient reports they need to see a cardiologist due to fluid build up around heart and there was enlargement of some area but she is unsure which part.Patient reports having a stress test with myocardial perfusion and a ct plumonary w/contrast on (b)(6) 2025.Patient reports she has recovered and has had no other complications.Patient provided the following medical history: she received ceftriaxone and daptomycin antibiotics that were being infused to treat a post-operative infection developed from a total ankle surgery.On (b)(6) 2025, she started iv antibiotics.In mid may, patient reports she had to have a flap and currently has an external fixater as part of treatment for the post op site infection, is having it removed in two weeks.

• Brand Name: CATHETER STABILIZATION, PICC/CENTRAL LINE
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22383129
• Report Number: 3006260740-2025-04490
• Device Sequence Number: 7101153
• Product Code: KMK
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 07/30/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown