MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP PORT ACCESS KIT 22G X 0.75IN WITH Y-SITE; HYPODERMIC SINGLE LUMEN NEEDLE.

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 reen2075 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported port needle device intact upon pre-flushing, patient port-a-cath accessed with device, on aspiration for blood return, noted blood drops forming at point where tubing connects to plastic clear port needle device.Equipment failure due to hole/ impairment.

• Brand Name: SAFESTEP PORT ACCESS KIT 22G X 0.75IN WITH Y-SITE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE.
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10121448
• Report Number: 3006260740-2020-01974
• Device Sequence Number: 3083343
• Product Code: FPA
• UDI-Device Identifier: 00801741085499
• UDI-Public: (01)00801741085499
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: PA-0029YN
• Device Lot Number: REEN2075
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243072-06/03/2020-006-R
• Patient Sequence Number: 1