MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

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 component is inconclusive due to the state of the returned sample.One 22 g x 0.75 in.Safestep infusion set in an opened package was returned for evaluation.An initial visual observation showed the safety mechanism was activated and the pinch clamp was engaged.A clear fluid was observed within the tubing.The needle guard and end cap were not returned with the sample.The opened state of the packaging made it difficult to assess when and where the component(s) went missing.Usage residue was observed on components within the kit which made determination of the exact timing and location of the missing component impossible.As a result, the event could have occurred at the manufacturing facility or following opening of the kit at the user facility.A lot history review (lhr) of asbys0039 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after opening the package, it was noticed that the cover of needle was not contained in it.The missing part was the needle cover of the device.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8951800
• MDR Text Key: 156399474
• Report Number: 3006260740-2019-02564
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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: LH-0029
• Device Lot Number: ASBYS0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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