MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFETY HUBER 22G 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 rebw1881 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the customer had leaking of huber needle while administering adriamycin.Called end customer, who explained the leaked was noted while administering the chemo drug.There was some leaking on to patient's skin, nurse was wearing ppe.Customer reports the leak was in the tubing outside of the dressing.
Additional Manufacturer Narrative
H11:section a through f - 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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling.Based on a review of this information, the following was concluded: the complaint of a leaking needle was inconclusive due to poor sample condition.Five photo samples of a 22 ga safety huber infusion set w/y-site was returned for evaluation.The five samples showed different angles of what appears to be the same device within a plastic container.The safety mechanism is fully activated over the needle.Blood residue is present within the tubing, proximal hub, and y-site hub.The event description indicates the leak was located at a region outside of the dressing.The extension tubing cannot be clearly inspected from the photo samples provided.The blood fluid present within the extension tubing may be from blood aspiration or presence of a leak.Since the alleged event could not be confirmed from the photos provided, the complaint remains inconclusive at this time.A lot history review (lhr) of rebw1881 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the customer had leaking of huber needle while administering adriamycin.Called end customer, who explained the leaked was noted while administering the chemo drug.There was some leaking on to patient's skin, nurse was wearing ppe.Customer reports the leak was in the tubing outside of the dressing.

• Brand Name: SAFETY HUBER 22G 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: 10121489
• Report Number: 3006260740-2020-01979
• Device Sequence Number: 16914843
• Product Code: FPA
• UDI-Device Identifier: 00801741044885
• UDI-Public: (01)00801741044885
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 583112
• Device Lot Number: REBW1881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1