MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSIONSET 20G X 0.75IN; 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	07/15/2020
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 asdxs0050 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported needle with leakage.No other information was provided.
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 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 a leak is confirmed but the exact cause remains unknown.One 20 ga x 0.75 in miniloc infusion set was returned for evaluation.The safety mechanism was engaged over the needle bevel.The extension tubing was clamped.Particulates within the extension tubing and adhesive residue on tubing were noted.The sample was flushed with water using a 12 ml syringe and no apparent leaks were noted.The needle was occluded in order to pressurize the device.Beads of fluid were observed to form at the interface between the extension tubing and needle housing.Microscopic observation of the leak location revealed a circumferential break in the adhesive fillet.The break in the fillet indicates the extension tubing may have experienced kinking and tensile forces which may have affected the adhesive bond.Since the leak was observed during functional testing of the device, the complaint is confirmed but the exact cause remains unknown.Possible contributing factors include excessive manipulation of the device and securement technique.
Event or Problem Description
It was reported needle with leakage.No other information was provided.

• Brand Name: MINILOC SAFETY INFUSIONSET 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: 10434588
• Report Number: 3006260740-2020-02995
• Device Sequence Number: 3218933
• Product Code: FPA
• UDI-Device Identifier: 00801741048784
• UDI-Public: (01)00801741048784
• Combination Product (Y/N): N
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 09/28/2022
• Device Model Number: N/A
• Device Catalogue Number: S02020-75
• Device Lot Number: ASDXS0050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1