MAUDE Adverse Event Report: BARD ACCESS SYSTEMS LIFTLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
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 disconnected extension leg was confirmed and the cause was determined to be use related.The product returned for evaluation was a 20ga x ¾¿ liftloc infusion set (w/ y-site).The sample contained usage residue throughout and the extension tube was disconnected from the needle base.Further evaluation confirmed that no remaining segment of tubing remained within the needle base and that the tubing had disconnected, and did not break.Tactile evaluation of the extension tubing found noticeable tensile strength loss as compared to a similar lab sample.Microscopic examination of the tubing region which had been attached to the needle base found that adhesive had been applied uniformly and in the correct location.The complainant had indicated that, ¿when patient work up, clothes and bedding was wet¿ and that the extension tube was discovered to be detached.The evidence observed on the returned device was supportive of the extension tube being pulled to the point of failure.No potential manufacture deficiency was observed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the patient was home receiving chemo through an auto pump.It was stated when patient woke up, clothes and bedding was wet.The patient noticed that the tubing had disconnected at the safety wing junction.No patient harm indicated.

• Brand Name: LIFTLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8364256
• Report Number: 3006260740-2019-00355
• Device Sequence Number: 2120669
• Product Code: FPA
• UDI-Device Identifier: 00801741047855
• UDI-Public: (01)00801741047855
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K013394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 0662034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1