MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 20G X 15MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SHN20-60
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of "rebt0397 or rebt2413" showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rebt0397 or rebt2413) were reported from the same facility in (b)(6).
Event or Problem Description
It was reported by the user, "port punctured saline solution (nacl) drips near the handle during injection.Air may be sucked in through the syringe.Leakage is not visible to the human eye.It may be a risk of air embolism." no reported patient injury.
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 from the infusion set was confirmed but the exact cause is unknown.One photo, video, and physical sample were provided for investigation.The video shows what appeared to be an ez huber infusion set submerged in water with air bubbles forming at the distal end of the needle housing.The needle was inserted partway into a non-vad port septum, which was most likely done to occlude the needle and pressurize the infusion set.One ez huber infusion set was returned for investigation.The safety mechanism bio bag appeared to have been removed and was returned separate from the infusion set.The needle tip was observed to be severely damaged.The infusion set was pressurized and flushed with water using a 12 ml syringe and a leak was observed at the distal top end of the needle housing.Microscopic observation of the needle housing revealed internal horizontal cracks.Based on the damaged observed at the needle bevel and needle housing, a possible contributing factor for the reported leak includes excessive force applied to the needle tip during use.Since the leak was observed during functional testing, the complaint is confirmed; however the exact cause of the damage could not be determined.A lot history review (lhr) of rebt0397 and rebt2413 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the user, " port punctured saline solution (nacl) drips near the handle during injection.Air may be sucked in through the syringe.Leakage is not visible to the human eye.It may be a risk of air embolism." no reported patient injury.
Additional Manufacturer Narrative
The initial complaint was reported as a bard access systems manufactured product.Upon further follow up with the complainant, it was clarified that the product involved in the reported event was a jetcan safe ii, which is not a product manufactured by bard access systems.
Event or Problem Description
It was reported by the user, " port punctured saline solution (nacl) drips near the handle during injection.Air may be sucked in through the syringe.Leakage is not visible to the human eye.It may be a risk of air embolism." no reported patient injury.10/12/2018 - pfm reported to us that the device involved in this event is a jetcan safe ii infusion set, which is not a bard device.
Event or Problem Description
It was reported by the user, " port punctured saline solution (nacl) drips near the handle during injection.Air may be sucked in through the syringe.Leakage is not visible to the human eye.It may be a risk of air embolism." no reported patient injury.(b)(6) 2018 - pfm reported to us that the device involved in this event is a jetcan safe ii infusion set, which is not a bard device.
Additional Manufacturer Narrative
Bard received information from the distributor that the needle involved in this event was a jetcan safe ii device, which is not manufactured or distributed by bd medical.However, an ez huber needle, which is manufactured by bd vad, was returned for evaluation and found to be leaking.A complete investigation of the received leaking infusion set was conducted.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 from the infusion set was confirmed but the exact cause is unknown.One photo, video, and physical sample were provided for investigation.The video shows what appeared to be an ez huber infusion set submerged in water with air bubbles forming at the distal end of the needle housing.The needle was inserted partway into a non-vad port septum, which was most likely done to occlude the needle and pressurize the infusion set.One ez huber infusion set was returned for investigation.The safety mechanism bio bag appeared to have been removed and was returned separate from the infusion set.The needle tip was observed to be severely damaged.The infusion set was pressurized and flushed with water using a 12 ml syringe and a leak was observed at the distal top end of the needle housing.Microscopic observation of the needle housing revealed internal horizontal cracks.Based on the damaged observed at the needle bevel and needle housing, a possible contributing factor for the reported leak includes excessive force applied to the needle tip during use.Since the leak was observed during functional testing, the complaint is confirmed; however the exact cause of the damage could not be determined.

• Brand Name: EZ HUBER 20G X 15MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7770708
• Report Number: 3006260740-2018-02027
• Device Sequence Number: 1258595
• Product Code: FPA
• UDI-Device Identifier: 00801741089671
• UDI-Public: (01)00801741089671
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2018

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: SHN20-60
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 10/12/2018; 10/12/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/21/2018; 11/03/2018; 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1