MAUDE Adverse Event Report: GEM V/NV 20D 0.2 FLTR; INTRAVASCULAR ADMINISTRATION SET

Model Number	2232-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the gem v/nv 20d 0.2 fltr experienced leakage.The following information was provided by the initial reporter: pt's methotrexate line was leaking from the filter (specifically the small dots on the back of the filter).Patient and mom noticed very small lime green dots on bed sheet (pt did not come in contact with the methotrexate).After discussing with pharmacy, family and the charge nurse, we decided the best thing to do would be to wrap the filter (tegaderm then wrapped with gauze and coban), and let the methotrexate finish (there was only 1.5 hrs left of 24 hr methotrexate).
Event or Problem Description
It was reported that the gem v/nv 20d 0.2 fltr experienced leakage.The following information was provided by the initial reporter: pt's methotrexate line was leaking from the filter (specifically the small dots on the back of the filter).Patient and mom noticed very small lime green dots on bed sheet (pt did not come in contact with the methotrexate).After discussing with pharmacy, family and the charge nurse, we decided the best thing to do would be to wrap the filter (tegaderm then wrapped with gauze and coban), and let the methotrexate finish (there was only 1.5 hrs left of 24 hr methotrexate).
Additional Manufacturer Narrative
H.6.Investigation: one used primary set, was received by the customer for investigation.A empty 250 ml bag of 0.9% sodium chloride was received as well.Upon visual inspection, it could be observed that the expected material 2232-0007 was not returned.Instead a filter free bd primary set attached to a icu medical filter extension set was returned.Since no defects were found with the returned bd product, the customer's complaint of leaking from the filter could not be verified.A device history record review could not be performed because a lot number was not provided by the customer.H3 other text : see h.10.

• Brand Name: GEM V/NV 20D 0.2 FLTR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12199824
• Report Number: 9616066-2021-51567
• Device Sequence Number: 1322914
• Product Code: FPA
• UDI-Device Identifier: 50885403463967
• UDI-Public: 50885403463967
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: Other
• Device Model Number: 2232-0007
• Device Catalogue Number: 2232-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1