MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
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 recx2486 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the port needle was connected to nacl, after about 1 hour, the nurse noticed that the infusion has completely run out.It was stated it leaked and dripped at the connection between luer and infusion line.
Event or Problem Description
It was reported the port needle was connected to nacl, after about 1 hour, the nurse noticed that the infusion has completely run out.It was stated it leaked and dripped at the connection between luer and infusion line.
Additional Manufacturer Narrative
The information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was inconclusive because the returned sample was not the originally implicated device.The product returned for evaluation was one 20ga x 1¿ huber plus safety infusion set.The sample was received in its original sealed packaging.The sample appeared unremarkable to gross inspection.Microscopic inspection of the sample did not reveal any damage, defect or evidence of leakage.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization.No deficiencies were discovered during evaluation of the returned sample; however, the sealed state of the sample packaging indicated that it was not the originally implicated device.Consequently this complaint is inconclusive at this time.

• Brand Name: HUBER PLUS 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8675663
• Report Number: 3006260740-2019-01563
• Device Sequence Number: 11351241
• Product Code: FPA
• UDI-Device Identifier: 00801741065552
• UDI-Public: (01)00801741065552
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 012001
• Device Lot Number: RECX2486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1