MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV SELECT MICRO 9IN BIFURACTED SMARTSITE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
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 for evaluation.
Event or Problem Description
It was reported by the customer iv tubing 2 port extending from iv cath is specifically malfunctioning when an iv tubing is pulled on or dislodged by the patient.This patient had removed all of his ivs this night and each one had malfunctioned/ broke in the same location which was the tubing connected to the end piece that connected directly to the iv cath that was inserted into the patient.Event occurred in patient room, but no harm was evident.No other information was provided.Additional information received 04 january 2024: it was reported by the customer "product disconnected at hub and bleeding was identified immediately, without harm.Event did not involve an urgent/life threatening medical situation.Device was discarded." it was reported this occurred with two devices.This report addresses the second device.

• Brand Name: STATLOCK IV SELECT MICRO 9IN BIFURACTED SMARTSITE 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18491293
• Report Number: 3006260740-2024-00062
• Device Sequence Number: 6991409
• Product Code: FPA
• UDI-Device Identifier: 00801741082061
• UDI-Public: (01)00801741082061
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980992
• 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
• Report Date (Section B): 01/10/2024

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: IV0566
• 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: 12/22/2023
• Initial Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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