MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 asdrf075 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "rn accessed patient port and after the needle was inserted, she flushed and the white cap closet to the needle/patient flew off and saline sprayed out onto the patient's shirt.Normal force was used when flushing.Product: (power loc max huber needle 19g 1 inch, ref#: 0131910, lot: asdr075).Cap on power loc max huber needle tubing port closest to the needle came off during flushing.Tubing did not appear to be cracked, cap did not stay on as it normally does, may have been loose or defective.Rn was able to place another sterile cap in place of cap that came off and finished flushing port.No patient harm.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9825599
• Report Number: 3006260740-2020-00839
• Device Sequence Number: 3086612
• Product Code: FPA
• UDI-Device Identifier: 00801741047329
• UDI-Public: (01)00801741047329
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• 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): 03/12/2020

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 Model Number: N/A
• Device Catalogue Number: 0131910
• Device Lot Number: ASDRF075
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR