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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

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), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing needle guard is confirmed and was determined to be supplier related.One 20 g x 0.75 in.Safestep infusion set with a valved y-site with what appears to be its original packaging was returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.No needle guard was returned with the sample and a slit was observed in the clear plastic of the returned packaging; the edges of this split were observed to flare outward on the outer side of the packaging.Under microscopic observation, the edges of the slit were observed to be mostly straight, flat, and well-defined.A non-complaint safestep package was pierced with the needle of a non-complaint safestep infusion set which was then pulled in a perpendicular direction in an attempt to recreate the slit observed in the returned packaging.The resulting damage in the non-complaint sample was compared with the damage observed on the returned packaging and was found to be very similar in shape and texture.The results of this testing suggest the needle of the alleged infusion set may have pierced its packaging from within the package, which may have been due to the lack of a guard on the needle.This device is a supplied component and the supplier has been notified of this event.A lot history review (lhr) of asdus0122 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported a nurse was opening a huber needle and the safety cover was not on the needle, resulting in the nurse poking her finger.Device was not used on a patient.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE
• 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: 9234442
• MDR Text Key: 164152048
• Report Number: 3006260740-2019-03324
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066214
• UDI-Public: (01)00801741066214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: N/A
• Device Catalogue Number: LH-0031YN
• Device Lot Number: ASDUS0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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