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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 recx1463 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the safety huber needle leaked.No other information was provided.
Event or Problem Description
It was reported the safety huber needle leaked.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leaking needle is inconclusive due to non-original product sample returned.74 sealed 20 ga x 0.75 in w/y-site safety huber infusion sets were returned for investigation.The product information showed lot: recx1463.The samples were opened.The proximal luer was flushed with water using a 12 ml syringe and no leaks were observed.The sample was then flushed through y-site valved connector.The distal clamp was then engaged, and the sample was pressurized through the proximal luer connector.A bead of water was observed to form at the blue valve on one of the samples.A continuous leak was not observed.The original sample which experienced the alleged event was not returned.It is unknown of the sample was exposed to excessive pressure during use or if any external was present to the tubing; therefore, the complaint is inconclusive.A lot history review (lhr) of recx1463 showed no other similar product complaint(s) from this lot number.

• 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: 9225028
• Report Number: 3006260740-2019-03291
• Device Sequence Number: 13498038
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 585112
• Device Lot Number: RECX1463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1