MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

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 a missing luer cap was inconclusive due to the nature of the returned sample.The product returned for evaluation was one photograph depicting a 20ga x 0.75¿ safestep safety infusion set.The sample appeared free of use residues.The clamp and the safety mechanism were both not engaged and the protective sleeve was covering the needle shaft.No end cap was attached to the luer adapter.An arrow pointing to the luer was included on the photograph.While no luer cap was evident in the submitted photograph, the device packaging was opened and the device was removed from the packaging, so the original state of the device could not be assessed.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of asdts0142 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the needle came without the safety cap.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE 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
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10192394
• MDR Text Key: 200021183
• Report Number: 3006260740-2020-02212
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0031
• Device Lot Number: ASDTS0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1