MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 20G X 0.75IN WITH NEEDLELESS Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of reeu4069 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reeu4069) have been reported from the same facility.
Event or Problem Description
It was reported "customer called in stating they have leak from the clave (white side) used for chemo patients.The leak occurred during the flush." additional info.Received 02/04/2021: "what theyre being treated for: metastatic poorly -differentiated adenocarcinoma of the lung with metastatic disease to bone, 'no patient harm reported" it was stated this occurred with two devices.This report addresses the first device.
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, 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 leakage at the y-site valve was confirmed.The product returned for evaluation was one 20ga x 0.75¿ ez huber safety infusion set with y-site.Usage residues were observed throughout the sample and the safety mechanism was engaged.A needleless injection cap was attached to the luer adapter.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, during functional testing, beads of water were observed emanating from the y-site valve.The leakage was non-continuous.Microscopic inspection of the valve did not reveal any defects or deformities.The beads of fluid appeared to occur intermittently under certain infusion/aspiration conditions.No continuous leakage was observed.
Event or Problem Description
It was reported "customer called in stating they have leak from the clave (white side) used for chemo patients.The leak occurred during the flush." additional info.Received 02/04/2021: "what they¿re being treated for: metastatic poorly -differentiated adenocarcinoma of the lung with metastatic disease to bone, 'no patient harm reported" it was stated this occurred with two devices.This report addresses the first device.

• Brand Name: EZ HUBER 20G X 0.75IN WITH NEEDLELESS Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11313527
• Report Number: 3006260740-2021-00311
• Device Sequence Number: 790785
• Product Code: FPA
• UDI-Device Identifier: 00801741089879
• UDI-Public: (01)00801741089879
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: SHW20-75YS
• Device Lot Number: REEU4069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 47