MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	S02019-75
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asbvs0178 showed (b)(4) other similar product complaint(s) from this lot number.The complaints for this lot number (asbvs0178) have been reported from the same complainant.
Event or Problem Description
The patient's mother reported that when she opened the miniloc to access her son's port the plastic needle covering was missing and she stabbed herself through her glove.She stated that she had to redo the sterile field and open another needle which was also missing the covering but she was able to place it.This report addresses the first device.

• Brand Name: MINILOC SAFETY INFUSION SET 19G 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: 7811510
• Report Number: 3006260740-2018-02211
• Device Sequence Number: 2347871
• Product Code: FPA
• UDI-Device Identifier: 00801741048708
• UDI-Public: (01)00801741048708
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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 Catalogue Number: S02019-75
• Device Lot Number: ASBVS0178
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1