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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of ascps0098 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the safety lock was broken.No other information was provided.
Additional Manufacturer Narrative
6/26/2019 - 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 broken safety is unconfirmed since the problem could not be reproduced.One 20 ga x 0.75 in miniloc infusion set was returned for investigation.The safety mechanism was returned partially advanced.An end cap was attached to the luer.No apparent damage was observed on the safety mechanism housing or needle shaft.The sample was flushed with water using a 12 ml syringe and was patent to infusion.The sample was pressurized, and no leaks were observed.The safety mechanism was able to be successfully activated over the needle tip and locked into place.Since functional testing of the device revealed no apparent issues, the complaint is unconfirmed.The instructions for use state, "stabilize the port by securely holding the powerloc finger tabs down; firmly pull the wings up until you hear or feel a ¿click¿ and visually observe the orange dot.".
Event or Problem Description
It was reported that the safety lock was broken.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: 8697381
• Report Number: 3006260740-2019-01654
• Device Sequence Number: 11351548
• 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): 07/02/2019

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: ASCPS0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1