MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
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 asbss0120 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s "patient states that she has powerport clearvue isp on (b)(6)2019.She states the first month access was stuck x 10 to access the powerport.She states that a chest x-ray was done to rule out a flipped port.Patient state the x-ray did not show a flipped powerport.She states the powerport is not perpendicular and cannot feel all 3 bumps on the powerport.Patient states that after 2 months after placement the powerport was accessed with miniloc safety infusion set s02020-10 and lot asbss0120 was used to access the powerport and on several occasions "popped out of the port".She states they switch needles and she is now using powerloc max safety infusion set 0142075 with lot asdqs0241.And that needle is "popping out of the port." she states the dressing is intact with needle popping out.She states she has many allergies and can only use the iv3000 dressing.She states she states accessed at home.Denies extreme movement of chest or arms.Ms&s suggested to try a longer needle due to the powerport not being perpendicular in the chest and the powerport being slanted." this report addresses the miniloc safety infusion set used.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9323859
• Report Number: 3006260740-2019-03552
• Device Sequence Number: 16229653
• Product Code: FPA
• UDI-Device Identifier: 00801741048722
• UDI-Public: (01)00801741048722
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: S02020-10
• Device Lot Number: ASBSS0120
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1