MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC PORT ACCESS KIT 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
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 redx4854 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the miniloc safety infusion set cracks and leaks chemotherapy drugs, approximately 24+ hours after being used with a pump.".
Event or Problem Description
It was reported "the miniloc safety infusion set cracks and leaks chemotherapy drugs, approximately 24+ hours after being used with a pump.".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx4854 showed two other similar product complaint(s) from this lot number.

• Brand Name: MINILOC PORT ACCESS KIT 20G X 0.75IN 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: 9793864
• Report Number: 3006260740-2020-00762
• Device Sequence Number: 16862402
• Product Code: FPA
• UDI-Device Identifier: 00801741044656
• UDI-Public: (01)00801741044656
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 2682034
• Device Lot Number: REDX4854
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1