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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascxs0024 showed no other similar product complaint(s) from this lot number.

Event Description

It was informed the needle shield was missing.The device was not used on a patient.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing needle guard is inconclusive due to the returned state of the sample.One 20 g x 0.75 in.Miniloc winged infusion set in an opened package was returned for evaluation.An initial visual observation showed no obvious evidence of use.A blue dust cap was returned on the luer hub of the infusion set, and one wing of the infusion set was returned in the cardboard of the packaging.No needle guard was returned.The opened state of the packaging made it difficult to assess when and where the needle guard went missing.Possible causes include improper kit packaging and misplacement of kit components after opening.A lot history review (lhr) of ascxs0024 showed no other similar product complaint(s) from this lot number.

Event Description

It was informed the needle shield was missing.The device was not used on a patient.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9256115
• MDR Text Key: 164418379
• Report Number: 3006260740-2019-03383
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741048784
• UDI-Public: (01)00801741048784
• Combination Product (y/n): N
• PMA/PMN Number: K050600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S02020-75
• Device Lot Number: ASCXS0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Event Location: Other
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1