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

Catalog Number	ADS201845
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer/compounder: (b)(4).The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that while performing an unspecified surgery with two units of floseal, the applicators reportedly broke and ¿lacerated the surgeon's hand¿.At the time of this report no further detail was provided regarding treatment, interventions for the event or the surgeon¿s outcome.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 and h10.Two devices were received for evaluation.It was reported that two applicators were broken; however, visual inspection was performed and no damage was observed on the applicators.It was identified that one side of the floseal syringe flange was broken off for both syringes.The location of the damage is not commonly observed.No additional issues were found during the sample analysis.One retention sample was reconstituted per the instructions for use (ifu).The thrombin solution was mixed into the gelatin syringe and the contents were mixed back and forth successfully between the syringes.The gelatin mixture was extruded out via the applicator with no issues were observed.The reported condition of broken applicator was not verified.The cause of the condition could not be determined; however, probable causes could be due to a user related handling issue.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: 12198381
• Report Number: 1416980-2021-04440
• Device Sequence Number: 14212238
• Product Code: LMF
• UDI-Device Identifier: 00085412639604
• UDI-Public: (01)00085412639604
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: ADS201845
• Device Lot Number: HA210499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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