MAUDE Adverse Event Report: INTRAVIA CONTAINER EMPTY; CONTAINER, I.V.

Catalog Number	2J8002
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred on an unspecified date, middle of june.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that (4) 250ml non-dehp fluid path intravia containers had precipitate inside the bags.This was identified after filling with sodium chloride or dextrose.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: seventeen (17) actual samples were received for evaluation.Visual inspection was performed using the naked in a lighted inspection for three (3) seconds against a white background and three (3) seconds against a black background and no particles were observed in all samples.The reported condition was not verified.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: INTRAVIA CONTAINER EMPTY
• Common Device Name: CONTAINER, I.V.
• MDR Report Key: 12269165
• Report Number: 1416980-2021-04740
• Device Sequence Number: 14734558
• Product Code: KPE
• UDI-Device Identifier: 00085412029573
• UDI-Public: (01)00085412029573
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K964853
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 2J8002
• Device Lot Number: DR21A19055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.