MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X .5"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recv2982 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recv2982) have been reported from the same facility in australia.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the extension tubing hub of the huber port access needle is cracking and leaking chemotherapy.No injury to patient.It was stated two from this batch have done this.This report addresses the first device.
Event or Problem Description
It was reported that the extension tubing hub of the huber port access needle is cracking and leaking chemotherapy.No injury to patient.It was stated two from this batch have done this.This report addresses the first device.
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 was inconclusive due to poor sample condition.Twenty-five sealed 20 ga x 0.5 in huber plus infusion sets were returned for investigation.The packaging information showed lot: recv2982.The samples were opened and functionally tested.An iso complaint taper gauge was used on the luer hubs and were found to be within specification.The infusion sets were then flushed and pressurized with water using a 12 ml syringe and no leaks or damage was observed.Since no apparent issues were observed on the returned lot samples, the complaint is inconclusive a lot history review (lhr) of recv2982 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recv2982) have been reported from the same facility in (b)(6).

• Brand Name: HUBER PLUS 20G X .5"
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8346223
• Report Number: 3006260740-2019-00293
• Device Sequence Number: 2285038
• Product Code: FPA
• UDI-Device Identifier: 00801741065576
• UDI-Public: (01)00801741065576
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 012005
• Device Lot Number: RECV2982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1