MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the miniloc needle being too short is inconclusive due to poor sample condition.Two photo samples of a miniloc infusion set were provided for investigation.The first photo shows the miniloc infusion set without the safety mechanism activated.The needle is being held a paper ruler.The needle appears to be between the 3/8th and 0.5 in ruler marks.The second photo shows the product labeling for a miniloc 20 ga x 0.5 in infusion set with lot: asdss0108.The exact measurement of the needle could not be determined through the photo sample provided.Since the reported issue could not be clearly evaluated from the photo sample provided, the complaint remains inconclusive.The instructions for use (ifu) state, "verify needle length is correct based on port reservoir depth, tissue thickness, and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or portal may be damaged at insertion; if too short, needle may not completely pierce portal septum, and medication may be delivered into surrounding tissue and/or needle may be blocked." a lot history review (lhr) of asdss0108 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "patients who were standard 0.5in huber needle had to be reaccesses because the miniloc wouldn't hit the back of the port.".

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.5IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9990453
• Report Number: 3006260740-2020-01494
• Device Sequence Number: 17253822
• Product Code: FPA
• UDI-Device Identifier: 00801741047572
• UDI-Public: (01)00801741047572
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2020

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: 04/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 0632050
• Device Lot Number: ASDSS0108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1