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 Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
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 that needle was with an issue with the safety lock.No other information was provided.
Event or Problem Description
It was reported that needle was with an issue with the safety lock.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, applicable previous investigation(s), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a defective safety mechanism was unconfirmed as the problem could not be reproduced.One 20 ga x 0.75 in miniloc infusion set was returned for evaluation.The safety mechanism was not engaged over the needle bevel.The extension tubing was clamped.No obvious evidence of use was noted on the device.The needle housing and wings appeared to be intact with no evidence of damage.The safety mechanism was advanced and was able to be successfully activated over the needle bevel.No resistance was felt during advancement.The safety mechanism was manipulated in order to test for potential deactivation.The mechanism stayed intact, and no issues were noted.Since the safety mechanism of the returned device was found to function as intended, the complaint could not be confirmed at this time.

• 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: 10434622
• Report Number: 3006260740-2020-02996
• Device Sequence Number: 19638030
• 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