MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	IV0564
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a cracked connector was confirmed; however, the exact cause could not be determined from the photograph that was provided for investigation.The photo showed a luer hub from what appeared to be an extension set packaged with the statlock stabilization device.A non-vad injection cap was attached to the luer hub and a syringe was attached to the injection cap.What was consistent with blood residue was observed within the extension set tubing.The reflected lighting on the luer hub was consistent with a crack in the luer material.Due to the condition of the device, it appeared that the product was damaged during use; however the cause of the crack could not be determined.A review of the manufacturing records revealed no manufacturing related issues that would have caused or contributed to the reported event.A lot history review (lhr) of judsf524 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (judsf524) have been reported from the same facility.
Event or Problem Description
It was reported that the iv tubing cracked at the hub.No other information was provided.

• Brand Name: STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 25 BOX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9035833
• Report Number: 3006260740-2019-02696
• Device Sequence Number: 2882502
• Product Code: FPA
• UDI-Device Identifier: 00801741082047
• UDI-Public: (01)00801741082047
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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 Expiration Date: 04/28/2022
• Device Model Number: IV0564
• Device Catalogue Number: IV0564
• Device Lot Number: JUDSF524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1