MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Exsanguination (1841); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
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.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that patient has a right radial aline.Aline separated from the hub connection of the stat lock extension.The tubing should be seal connected but the tubing came apart.Aline was placed on (b)(6) 2023 in the or.The stat lock could be from the aline kit.Patient had a blood loss while attempting to discern the area of leaking and disconnection.The event did not involve a life-threatening or urgent medical situation.
Event or Problem Description
It was reported by the customer that patient has a right radial aline.Aline separated from the hub connection of the stat lock extension.The tubing should be seal connected but the tubing came apart.Aline was placed on (b)(4) 2023 in the or.The stat lock could be from the aline kit.Patient had a blood loss while attempting to discern the area of leaking and disconnection.The event did not involve a life-threatening or urgent medical situation.
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.
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 detached extension set luer adapter was confirmed.The sample was evaluated and this event was determined to be related to a manufacture condition.Bd is working to prevent future occurrences of similar events and values your support and partnership in communicating this event and coordinating the return of the sample.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer that patient has a right radial aline.Aline separated from the hub connection of the stat lock extension.The tubing should be seal connected but the tubing came apart.Aline was placed on (b)(6) 2023 in the or.The stat lock could be from the aline kit.Patient had a blood loss while attempting to discern the area of leaking and disconnection.The event did not involve a life-threatening or urgent medical situation.

• Brand Name: STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 25 BOX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 17491676
• Report Number: 3006260740-2023-03425
• Device Sequence Number: 7293810
• Product Code: FPA
• UDI-Device Identifier: 00801741081279
• UDI-Public: (01)00801741081279
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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: ART0220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/06/2023; 10/18/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/20/2023; 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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