MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascxs0084 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
After opening the package of the indwelling needle, it is found that there is foreign matter at the pipe joint.

• Brand Name: POWERLOC SAFETY INFUSION SET 22G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10368592
• Report Number: 3006260740-2020-02764
• Device Sequence Number: 3094213
• Product Code: FPA
• UDI-Device Identifier: 00801741048364
• UDI-Public: (01)00801741048364
• Combination Product (Y/N): N
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 8652234
• Device Lot Number: ASCXS0084
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1