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	01/27/2020
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 asdqs0010 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported miniloc needle with loose safety lock.Device was not used on a patient.No other information was provided.
Event or Problem Description
It was reported miniloc needle with loose safety lock.Device was not used on a patient.No other information was provided.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damaged safety mechanism was confirmed but the exact cause remains unknown.One 20 ga x 0.75 in miniloc infusion set was returned for evaluation.The orange component from the safety mechanism was returned detached from the winged needle housing.No apparent material damage was visible on the plastic components of the device.The needle was observed to be bent; however, it is unknown if the bend occurred during or after use.The safety mechanism could not be activated without proper assembly of the components.The orange component was able to be reinserted in the safety mechanism housing which allowed proper functionality of the safety mechanism.The condition of the device prior to use is unknown, the exact cause could not be determined.A lot history review (lhr) of asdqs0010 showed no other similar product complaint(s) from this lot number.

• 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: 10314939
• Report Number: 3006260740-2020-02675
• Device Sequence Number: 11625859
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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 Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: S02020-75
• Device Lot Number: ASDQS0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1