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	07/01/2023
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 art disconnect alarm sounded, went in room, pt bleeding significantly from a line site, said she barely moved.Pressure held immediately but unable to get good control d/t location of tube breakage.Eventually pressure was successfully held.On inspection tube was cracked in half/broken.Pt stable, comfortable, attending at bedside aware.The event occurred on (b)(6) 2023.Response received (b)(6)2023 device did not break during treatment.Patient bleeding significantly from a line site, pressure held immediately but unable to get good control d/t location of tube breakage.Eventually pressure was successfully held.
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 available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of extension set luer detachment was confirmed.The returned sample 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 art disconnect alarm sounded, went in room, pt bleeding significantly from a line site, said she barely moved.Pressure held immediately but unable to get good control d/t location of tube breakage.Eventually pressure was successfully held.On inspection tube was cracked in half/broken.Pt stable, comfortable, attending at bedside aware.The event occurred on (b)(6) 2023.Response received (b)(6) 2023 device did not break during treatment.Patient bleeding significantly from a line site, pressure held immediately but unable to get good control d/t location of tube breakage.Eventually pressure was successfully held.

• 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: 17367890
• Report Number: 3006260740-2023-03095
• Device Sequence Number: 17660432
• 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