MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT START KIT MACRO 6IN ULTRASITE 50 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	IVK0119
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of juctf090 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juctf090) have been reported from the same facility.Mw5079176; (b)(4).
Event or Problem Description
Per medwatch: nuclear medicine tech was injecting nuclear isotope and the iv extension set leaked.Upon review of the extension set, a crack was noted at the connection site.On 09/19/2018 additional information stated, "the cracked hub was found during placement and use, the device leaked when injected.No harm to the patient".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a connector crack is confirmed but the exact cause is unknown.One 6¿ iv extension tubing with an infusion cap attached to the hub was returned for investigation.Use residue was present within the tubing.The sample was flushed with water using a 12 ml syringe and a leak was observed at the hub of the extension set.The infusion cap was removed and a crack in the hub was observed extending from the proximal end of the hub down to where the hub wings in a ¿j¿ shape.Spiraled fracture marks are visible on the inner surface of the hub near the crack length.The male segment of the infusion cap appeared to have scratch marks on the outer surface.Based on the condition of the returned sample, possible contributing factors include over-tightening of the connector and damage during handling.Since the crack was observed on the hub connector, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of juctf090 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juctf090) have been reported from the same facility.Mw5079176.
Event or Problem Description
Per medwatch: nuclear medicine tech was injecting nuclear isotope and the iv extension set leaked.Upon review of the extension set, a crack was noted at the connection site.09/19/2018 additional information stated, "the cracked hub was found during placement and use, the device leaked when injected.No harm to the patient".

• Brand Name: STATLOCK IV SELECT START KIT MACRO 6IN ULTRASITE 50 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: 7936755
• Report Number: 3006260740-2018-02731
• Device Sequence Number: 930442
• Product Code: FPA
• UDI-Device Identifier: 00801741082450
• UDI-Public: (01)00801741082450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K980992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018
• Report Date (Section F): 08/14/2018

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: IVK0119
• Device Catalogue Number: IVK0119
• Device Lot Number: JUCTF090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 56
• Date Report Sent to FDA: 08/14/2018