MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 20G X 19MM WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Crack (1135)
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 is pending evaluation.Results are expected soon.A lot history review (lhr) of redt4269 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the ez huber was primed and connected to patients port.The chemotherapy infusion started and was due to last for 2 hours.During the last 30 minutes, the patient complained of damp clothing in the surrounding area of the port.The nurse immediately disconnected the infusion pump from the ez huber.She then unscrewed the green needle free bung on the secondary arm of the huber needle extension.A small crack was observed just below the luer lock part of the extension line.The nurse then used saline to flush the arm to confirm the crack and then saw the saline squirt out of the crack.
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, 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 leak at the y-site was confirmed, but the exact cause was unknown.One 20g ez huber infusion set was returned for investigation.The infusion set revealed evidence of use.Non-vad injection caps were attached to the y-site and the luer adaptor at the proximal end of the infusion set.What appeared to be blood residue was observed in the extension set tubing between the y-site and the needle.A functional test revealed fluid leaking from the side of the y-site.A longitudinal crack was observed in the y-site along the knit line that was located opposite from the injection gate mark.The cracks was 10.5mm in length.It appeared that the infusion sets were damaged during use; however, the exact mechanism of damage was unknown.----------------------------------------------------------------------------------------------------- reynosa evaluation complaint due to ¿small crack was observed just below the luer lock¿ was confirmed but the exact cause is unknown.According with the photo evaluation performed at reynosa facility and gross visual, microscopical visual performed at vad lab the following was concluded: a longitudinal crack on the thread y-connector was found to be present causing leakage.Damage during the manufacturing process may be a potential root cause/contributor to the observed luer hub crack.However, no findings from the dhr review indicated a manufacturing/processing related event.Damage by overtightened during use, however, the exact mechanism of damage was unknown.Therefore, as the definitive root cause of the damage could not be determined the cause of this condition remains unknown.A lot history review (lhr) of redt4269 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the ez huber was primed and connected to patients port.The chemotherapy infusion started and was due to last for 2 hours.During the last 30 minutes, the patient complained of damp clothing in the surrounding area of the port.The nurse immediately disconnected the infusion pump from the ez huber.She then unscrewed the green needle free bung on the secondary arm of the huber needle extension.A small crack was observed just below the luer lock part of the extension line.The nurse then used saline to flush the arm to confirm the crack and then saw the saline squirt out of the crack.

• Brand Name: EZ HUBER 20G X 19MM WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9788927
• Report Number: 3006260740-2020-00727
• Device Sequence Number: 19386965
• Product Code: FPA
• UDI-Device Identifier: 00801741089244
• UDI-Public: (01)00801741089244
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/30/2020

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: SHG20-75Y
• Device Lot Number: REDT4269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1