MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 25MM WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
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) of rebs0476 showed no other similar product complaint(s) from this lot number.Device not yet returned.
Event or Problem Description
Patient called oncology treatment centre as her 5fu pump was leaking.Patient advised to clamp off at the implanted port, and to come in asap for review.On arrival, patient had put the 5fu pump in a plastic bag and clearly chemotherapy was leaking quite a bit in the bag.Patients skin was cleaned with saline and gauze no skin damage.No signs of redness, swelling or burning.Removed pump from the implanted port, and as i flushed the port to assess, it was leaking from a crack in the y connector of the ez huber needle.Implanted port de-accessed, and re-accessed again.Port flushing, patent with good blood return.5fu pump reattached.Patient advised to go home and shower body, clean towels bedlinen clothes and any material contact with chemotherapy in a separate wash on a high heat with biological washing liquid and to call us if she notices any burning redness or swelling around the port a cath site.

• Brand Name: EZ HUBER 22G X 25MM 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: 8533558
• Report Number: 3006260740-2019-01123
• Device Sequence Number: 360577
• Product Code: FPA
• UDI-Device Identifier: 00801741089275
• UDI-Public: (01)00801741089275
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: SHG22-100Y
• Device Lot Number: REBS0476
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1