MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 CATHETER STABILIZATION, ARTERIAL

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
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.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.
Event or Problem Description
It was reported we had an arterial line statlock that slid off of the end of the pressure tubing extension set which is supposed to be kind of sodered/ glued together and not supposed to come apart.This was identified quickly, but blood was flowing out from the line as it was no longer tightly connected.The top luer lock area (which is bloody) is where it disconnected the pooped off piece is right below its normal glued attachment.The nurse placed an on point.Additional information: when the line popped apart the high alarm went off and the nurse went right in.Blood was coming out from the open arterial line but the nurse intervened immediately to stop the flow of blood.Visitors were in the room and reported that the patient was not moving or doing anything that might have disturbed the arterial line.Patient harm was prevented.
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 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 damaged extension set is confirmed; however, the exact cause is unknown.One photograph of an extension set was returned for evaluation.An initial visual observation of the photograph showed the luer hub on the distal end of the device was disconnected from the extension tubing.The details of the disconnected tube and luer hub could not be discerned from the returned photo.The slide clamp was removed from the extension tubing.Use residue was observed on and around the device.No other damage was observed.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: CATHETER STABILIZATION, ARTERIAL
• Common Device Name: CATHETER STABILIZATION, ARTERIAL
• 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: jomil padin ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22031555
• Report Number: 3006260740-2025-03150
• Device Sequence Number: 20958169
• Product Code: FPA
• UDI-Device Identifier: 00801741081354
• UDI-Public: (01)00801741081354(11)250125(17)271128(10)JUJZ8604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

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: ART0420
• Device Lot Number: JUJZ8604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 06/24/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2025
• 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