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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/17/2019
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 asczs0081 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the orange device came off and the needle left the safety base.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of damaged safety mechanism is confirmed but the exact cause could not be determined.One 20 ga x 0.75 in miniloc infusion set was returned for investigation.The device was returned in open packaging with ref: s02020-75 lot: ascz0081.The orange component from the safety mechanism was returned detached from the safety mechanism assembly.Microscopic observation of the safety mechanism assembly did not reveal any apparent mechanical damage.The safety mechanism could not be fully activated.The orange component was able to be reassembled and the safety mechanism was able to be successfully advanced.Based on the condition of the returned sample, possible contributing factors include excessive manipulation of the device and improper assembly.The condition of the device prior to package opening could not be determined; therefore, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of asczs0081 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the orange device came off and the needle left the safety base.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: 9290428
• Report Number: 3006260740-2019-03495
• Device Sequence Number: 16756383
• 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): 12/23/2019

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: ASCZS0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1