MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD STATLOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	06/30/2023
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned.
Event or Problem Description
It was reported by customer that the extension tubing broke off from catheter hub on (b)(6) 2023 around 8:30p.Pt was asleep in chair, nurse saw on monitor at nurses station that "art 1 line has disconnected" beeping on the monitor.Multiple nurses ran into room and saw that patient was bleeding from arterial line catheter onto gown and chair.Nurse applied pressure to site immediately with gauze and held for 5 minutes.A pressure dressing was applied.Vital signs remained stable throughout incident.Patient denied any lightheadedness or dizziness afterwards.Response received (b)(6) 2023.Device did not break during treatment.Patient bleed from arterial line, pressure applied and bleeding eventually controlled.
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.Based on a review of this information, the following was concluded: the complaint of a detached luer-lock adaptor was confirmed.The returned arterial statlock extension set tubing was found to exhibit the same features as a known issue.H3 other text : evaluation findings are in section h11.
Event or Problem Description
It was reported by customer that the extension tubing broke off from catheter hub on (b)(6) around 8:30p.Pt was asleep in chair, nurse saw on monitor at nurses station that "art 1 line has disconnected" beeping on the monitor.Multiple nurses ran into room and saw that patient was bleeding from arterial line catheter onto gown and chair.Nurse applied pressure to site immediately with gauze and held for 5 minutes.A pressure dressing was applied.Vital signs remained stable throughout incident.Patient denied any lightheadedness or dizziness afterwards.Response received 18 july 2023.Device did not break during treatment.Patient bleed from arterial line, pressure applied and bleeding eventually controlled.

• Brand Name: BARD STATLOCK
• 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: 17367889
• Report Number: 3006260740-2023-03094
• Device Sequence Number: 17660431
• Product Code: FPA
• UDI-Device Identifier: 00801741081378
• UDI-Public: (01)00801741081378
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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
• Report Date (Section B): 10/27/2023
• 2 Devices were Involved in the Event: 1 2

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: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/31/2023
• 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