MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLOSEAL; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number	ADS201845
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
C name and strength: floseal fast prep hemostatic matrix, 10 ml.Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a floseal fastprep kit was missing the sterile packaging.This was identified prior to use.There was no damage to the package or shipping materials.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h3, h6.H10: the actual device was received for evaluation.Visual inspection was performed which identified the sterile packaging missing from the component card.The reported condition was verified on the actual sample.The cause could not be determined; however the most probable cause would be mishandling of the kit box after shipment.Ten (10) retention samples were visually inspected; no missing components were noted.The reported condition was not verified on the retention samples.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: FLOSEAL
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10638323
• Report Number: 1416980-2020-06242
• Device Sequence Number: 3303078
• Product Code: LMF
• UDI-Device Identifier: 00085412639604
• UDI-Public: (01)00085412639604
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P990009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: Other
• Device Expiration Date: 12/10/2021
• Device Catalogue Number: ADS201845
• Device Lot Number: HA200659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1