MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVASCULAR EXTENSION SETS AND ACCESSORIES; FILTER, INFUSION LINE

Catalog Number	2N3359
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the packaging of a mini-volume extension set was found damaged.The was identified before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection revealed a small scratch on the packaging.The reported condition was verified.The cause of the condition was not determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11720157
• Report Number: 1416980-2021-02391
• Device Sequence Number: 19791607
• Product Code: FPB
• UDI-Device Identifier: 00085412639352
• UDI-Public: (01)00085412639352
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K192366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 2N3359
• Device Lot Number: DR20B28011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1