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

Catalog Number	S02020-10
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/22/2018
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of asaxs0245 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that during handling it was observed saline leakage at cannula connection.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak at the connector was confirmed and the cause appeared to be supplier related.One 20g miniloc infusion set was returned for investigation.A functional test of the device revealed fluid leaking from between the distal end of the connector and the extension set tubing.A microscopic examination of the infusion set revealed no adhesive fillet between the distal end of the luer connector and the extension set tubing.Adhesive, however, was observed around the circumference of the luer connector.It appears that the application of adhesive missed its mark.Due to what appeared to be a workmanship issue, the supplier was notified of this complaint.A lot history review (lhr) of asaxs0245 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during handling it was observed saline leakage at cannula connection.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: 7852946
• Report Number: 3006260740-2018-02365
• Device Sequence Number: 1431719
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: S02020-10
• Device Lot Number: ASAXS0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/10/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1