MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 19MM WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 recv2131 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the patient had received iv immunoglobulins and pre iv medications (rantidine and chlorphenamine) for 2.5 hours before the leak was identified.Chemotherapy was being administrated for 45 mins via an infusion pump running at 100mls.From the start of the infusion the pump was increased x 3 every 15 mins.The patient noticed their clothes were wet and fluid leaking from y-site.It was stated infusion stopped and ez needle flushed n/saline 0.9% the nurse drew back blood to ensure needle was in correct position on the port the needle bled back but leaked though the y site on the needle.
Event or Problem Description
It was reported the patient had received iv immunoglobulins and pre iv medications (rantidine and chlorphenamine) for 2.5 hours before the leak was identified.Chemotherapy was being administrated for 45 mins via an infusion pump running at 100mls.From the start of the infusion the pump was increased x 3 every 15 mins.The patient noticed their clothes were wet and fluid leaking from y-site.It was stated infusion stopped and ez needle flushed n/saline 0.9% the nurse drew back blood to ensure needle was in correct position on the port the needle bled back but leaked though the y site on the needle.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed but the exact cause remains unknown.Two ez huber infusion sets were returned for investigation.One sample was returned in sealed packaging.The second sample was returned without the packaging and the safety mechanism engaged.Usage residue was observed.The used sample was flushed with water using a 12 ml syringe and water was observed to leak at the y-site connector.Microscopic observation of the leak location revealed a longitudinal crack starting at the proximal end of the y site connector.The crack extends down to the y site extension leg stem section of the hub.Material whitening is observed surrounding the crack surfaces indicating that an outward radiating force was applied from within the connector.The crack was likely initiated by the advancement of a tapered object into the hub; however, the exact conditions the hub was exposed prior to or after packaging are unknown.The sealed sample was opened and no apparent issues were observed.It was then flushed and was found to be patent to infusion.Since the leak in the hub was found to be caused by a crack in the connector, the complaint is confirmed.A lot history review (lhr) of recv2131 showed no other similar product complaint(s) from this lot number.

• Brand Name: EZ HUBER 22G X 19MM WITH 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: 8341285
• Report Number: 3006260740-2019-00270
• Device Sequence Number: 13941621
• Product Code: FPA
• UDI-Device Identifier: 00801741089343
• UDI-Public: (01)00801741089343
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: SHG22-75Y
• Device Lot Number: RECV2131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1