MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 19G X 1IN NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reby0669 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that nurse opened this set of huber needle and started to prime the huber needle with 10 cc heparin saline.She felt resistance of infusing huber needle from the luer lock syringe and huber tube was not clamped.She infused slightly harder and found that only a few drops of heparin saline were out from huber needle.She stopped infusing and informed her nurse manager immediately.Nurse manger instructed the nurse to open a new box of huber needle for this patient.
Event or Problem Description
It was reported that nurse opened this set of huber needle and started to prime the huber needle with 10cc heparin saline.She felt resistance of infusing huber needle from the luer lock syringe and huber tube was not clamped.She infused slightly harder and found that only a few drops of heparin saline were out from huber needle.She stopped infusing and informed her nurse manager immediately.Nurse manger instructed the nurse to open a new box of huber needle for this patient.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty infusing is confirmed and appears to be manufacturing related.One 19 ga x 1 in huber plus infusion set was returned for investigation.No apparent use residue was observed on the device; however, fluid was present within the tubing.The sample was flushed with water using a 12 ml syringe and resistance was felt.Droplets of water were observed to flow out of the distal end of the needle.The distal end of the extension tubing was cut to observed the proximal end of the needle housing.Solid, clear material observed to be occluding the proximal end of the needle housing.A wire was used to puncture a hole through the material.The material is likely adhesive used in the manufacturing process.The manufacturing plant has implemented corrective actions.The reported lot was manufactured prior to implementation of corrective actions.A lot history review (lhr) of reby0669 showed no other similar product complaint(s) from this lot number.

• Brand Name: HUBER PLUS 19G X 1IN NEEDLELESS Y SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8804107
• Report Number: 3006260740-2019-02036
• Device Sequence Number: 10844525
• Product Code: FPA
• UDI-Device Identifier: 00801741065484
• UDI-Public: (01)00801741065484
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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 Model Number: N/A
• Device Catalogue Number: 011901NY
• Device Lot Number: REBY0669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1