MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
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 ascys0137 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that bevel inclination and burrs on the tip of the needle.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged needle tip is confirmed and was determined to be use related.One 20 x 0.75 in.Miniloc winged infusion set was returned for evaluation.An initial visual observation showed use residue on the returned sample.A microscopic observation revealed the tip of the needle was barbed and curled outward, suggesting contact between the needle and the port base.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness, and the thickness of any dressing beneath the bend of the needle; if the needle is too long, the needle and/or port may be damaged at insertion.Additionally, it is advised to avoid manipulation of the needle and infusion set once the needle is inserted into the port.A lot history review (lhr) of ascys0137 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that bevel inclination and burrs on the tip of the needle.No other information was provided.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9287355
• Report Number: 3006260740-2019-03481
• Device Sequence Number: 13491597
• Product Code: FPA
• UDI-Device Identifier: 00801741048784
• UDI-Public: (01)00801741048784
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: S02020-75
• Device Lot Number: ASCYS0137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1