MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFETY HUBER 20G X 0.75IN WITH NF VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	585112
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 be evaluated.Results are expected soon.A lot history review (lhr) of rebv1387 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility has ran across issues with the safety huber needle.This file is for the white connector leakage.No other details provided.
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 at the white connector is confirmed.15 20 ga x 0.75 in safety huber infusion sets were returned for investigation.The samples were returned in their sealed packaging.The samples were opened and functionally tested with water using a 10 ml syringe.The samples were flushed at the y-site, then clamped using the distal clamp, and then flushed from the proximal luer.On two of the samples a bead of water was observed to form at the blue valve of the y-site.The ifu states ¿needleless y-injection site valve may leak slightly at certain pressures resulting in a small bead of fluid on the valve.¿ this reported addresses sample 1.A lot history review (lhr) of rebv1387 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebv1387) have been reported from the same facility.
Event or Problem Description
It was reported that the facility has had issues with the safety huber needle leaking at the white hub/blue valve.No other details were provided.

• Brand Name: SAFETY HUBER 20G X 0.75IN WITH NF VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7604008
• Report Number: 3006260740-2018-01406
• Device Sequence Number: 16567619
• Product Code: FPA
• UDI-Device Identifier: 00801741044922
• UDI-Public: (01)00801741044922
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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 Catalogue Number: 585112
• Device Lot Number: REBV1387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1