MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MICRO 9IN BIFURCATED SMARTSITE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet received.
Event or Problem Description
It was reported the extension at the y point of the statlock device broke completely away from the body of the device.It was stated, "the infusion tubing at that point fell to the floor and we were unable to complete the patient¿s therapy.The device was leaking at that connection point before it broke off completely.We tried to redress the iv with a new device and dressing but were unable to keep the iv line in place.The patient lost approximately 20% of the drug and declined a new iv start.".
Event or Problem Description
It was reported the extension at the y point of the statlock device broke completely away from the body of the device.It was stated, "the infusion tubing at that point fell to the floor and we were unable to complete the patient¿s therapy.The device was leaking at that connection point before it broke off completely.We tried to redress the iv with a new device and dressing but were unable to keep the iv line in place.The patient lost approximately 20% of the drug and declined a new iv start.".
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken statlock extension set was confirmed; however, the cause was unknown.The product returned for evaluation was eight photographs depicting an extension set with y-site.Fluid residue was observed and needleless injection caps were attached to both female luer adapters.The depicted device exhibited either a break or detachment at one y-site/proximal tubing joint.Extension set damage was evident in the supplied photographs; however, inspection of those photographs were insufficient to identify the cause of that damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include tensile (pulling) stress and sharp instrument contact.

• Brand Name: STATLOCK IV SELECT MICRO 9IN BIFURCATED SMARTSITE 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: 8574960
• Report Number: 3006260740-2019-01250
• Device Sequence Number: 1537034
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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 Model Number: N/A
• Device Catalogue Number: IV0566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1