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

Catalog Number ADS201845

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 06/22/2021

Event Type  Injury  

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 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.

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
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12198381
• MDR Text Key: 262915323
• Report Number: 1416980-2021-04440
• Device Sequence Number: 1
• Product Code: LMF
• UDI-Device Identifier: 00085412639604
• UDI-Public: (01)00085412639604
• Combination Product (y/n): Y
• PMA/PMN Number: P990009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other