MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 19G X 0.75IN WITH NEEDLELESS Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SHW19-75YS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported the nurse attempted to de-access port and safety needle, and upon de-access, needle became detached from hub.No patient harm was reported.
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 that the needle detached from the housing was confirmed, but the cause could not be determined from the sample evaluation.One ez huber infusion set without a y-site and with a yellow clamp was returned for investigation.The condition of returned sample matched the event description, but the sample did not match the implicated product code.The reported product code was for a 19g x 3/4" ez huber infusion set with needleless y-injection site.Based on the clamp color, a 20g ez huber infusion set without y-site was returned for investigation.The needle was not attached to the housing and was not returned for investigation.Evidence of use was observed on the sample.An injection cap was attached to the luer hub and tape residue was observed on the external surface of the extension set tubing.The bio-bag was received extended away from the needle housing.The bio-bag was cut away from the needle housing.A microscopic examination of the adhesive revealed nothing remarkable.Adhesive coverage within the needle housing appeared to be uniform and complete.Nothing remarkable was observed on the adhesive fillet that had formed around the needle.The needle housing was bisected and nothing remarkable was observed on the adhesive coverage.An edge at the proximal end of the adhesive and the surface texture of the adhesive indicated that the needle was fully inserted within the housing.Since it appeared that the needle was properly assembled within the needle housing, the cause of the detachment was unknown.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported the nurse attempted to de-access port and safety needle, and upon de-access, needle became detached from hub.No patient harm was reported.

• Brand Name: EZ HUBER 19G X 0.75IN WITH 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: 7896191
• Report Number: 3006260740-2018-02529
• Device Sequence Number: 1395125
• Product Code: FPA
• UDI-Device Identifier: 00801741089770
• UDI-Public: (01)00801741089770
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: SHW19-75YS
• Device Catalogue Number: SHW19-75YS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1