MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 22G 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	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of asaus0169 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 the security lock was broken.
Event or Problem Description
It was reported that the security lock was broken.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the safety mechanism not remaining secure against the needle housing was confirmed; however, the root cause was not identified.The product returned for evaluation was one 22ga x 0.75¿ miniloc safety infusion set.The sample was received with the safety not engaged and appeared free of usage residues.The safety mechanism was extended slightly away from the housing.Attempts to secure the safety to the needle housing were unsuccessful.Microscopic inspection of the safety mechanism retention clip revealed deformation, which prevented retention of the safety mechanism.One tab was bent inward and material discoloration was observed in the vicinity of the bend.The inward edges of both tabs exhibited material wear.The safety mechanism would not remain secure against the housing because the retaining clip was deformed; however, the cause of that deformation was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include device manipulation prior to or during attempted use.A lot history review (lhr) of asaus0169 showed no other similar product complaint(s) from this lot number.

• Brand Name: MINILOC SAFETY INFUSION SET 22G 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: 8483086
• Report Number: 3006260740-2019-00771
• Device Sequence Number: 1870780
• Product Code: FPA
• UDI-Device Identifier: 00801741048869
• UDI-Public: (01)00801741048869
• 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): 05/07/2019

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: S02022-75
• Device Lot Number: ASAUS0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1