MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; 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	05/18/2020
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 asdus0012 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported needle leaked prior to use on a patient.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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set is unconfirmed as the alleged issue could not be reproduced.One 20 g x 1 in.Miniloc infusion set was returned for evaluation.An initial visual observation showed some use residue on the returned sample.The returned sample was flushed and pressurized with a 12 ml syringe of water; however, no leaks were found in the infusion set.The sample was found to be patent to infusion and aspiration, and no leakage was observed when the infusion set was also infused and pressurized with a slip-fit style syringe.A microscopic observation revealed some plastic deformation on one of the treads of the luer hub.The inner diameter of the hub was found to be within specification.While the alleged problem was unable to be reproduced with the returned sample, an incomplete or incorrect connection to the luer hub could allow for some leakage between the luer hub and the connected device; however, this was not able to be replicated during evaluation of the returned sample.A lot history review (lhr) of asdus0012 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported needle leaked prior to use on a patient.No other information was provided.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10314936
• Report Number: 3006260740-2020-02672
• Device Sequence Number: 3451243
• Product Code: FPA
• UDI-Device Identifier: 00801741048722
• UDI-Public: (01)00801741048722
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 06/28/2022
• Device Model Number: N/A
• Device Catalogue Number: S02020-10
• Device Lot Number: ASDUS0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1