MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV PLUS TRAPEZOIDAL PAD CLAMSHELL MACRO BORE 6IN LUER LOCK EXT SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2023
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.
Event or Problem Description
It was reported, "tubing is coming away from hub/snapping off.Incident happened on ward and attached to patient." no other information was provided.

• Brand Name: STATLOCK IV PLUS TRAPEZOIDAL PAD CLAMSHELL MACRO BORE 6IN LUER LOCK EXT SET
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17122284
• Report Number: 3006260740-2023-02420
• Device Sequence Number: 12620982
• Product Code: FPA
• UDI-Device Identifier: 00801741081712
• UDI-Public: (01)00801741081712
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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: IV0225
• Device Lot Number: UNKNOWN
• 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: 05/25/2023
• Initial Report FDA Received Date: 06/13/2023
• 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