MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a breach in the bond between the extension set tubing and the luer adaptor was confirmed and the cause appeared to be supplier related.One 20g miniloc infusion set was returned for investigation.A functional test revealed fluid leaking from the distal end of the luer adaptor.A microscopic examination revealed a gap in the adhesive coverage between the extension set tubing and the luer adaptor.It appeared that the extension set tubing was positioned correctly, but the adhesive was not uniformly distributed around the extension set tubing.The outside diameter of the extension set tubing was within specification.Due to the variation in adhesive coverage that allowed fluid to leak, the complaint appeared to be supplier related.The supplier was notified of this complaint.A lot history review (lhr) of asaws0060 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the extremity of the cannula was cracked.On 6/20/2019, the returned sample leaked at tube connection.

• 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: 8777638
• Report Number: 3006260740-2019-01902
• Device Sequence Number: 16647758
• Product Code: FPA
• UDI-Device Identifier: 00801741048722
• UDI-Public: (01)00801741048722
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: S02020-10
• Device Lot Number: ASAWS0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Event Location: Outpatient Diagnostic Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1