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

Catalog Number	1505291
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2018
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 two pieces of a floseal syringe broke off and into a patient during surgery.The broken pieces were from grip of the barrel of the syringe and were removed from the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed that the syringe was broken.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: FLOSEAL
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): BAXTER HEALTHCARE - HAYWARD; hayward CA
• MDR Report Key: 7245452
• Report Number: 1416980-2018-00580
• Device Sequence Number: 11023629
• Product Code: LMF
• UDI-Device Identifier: 00085412532868
• UDI-Public: (01)00085412532868
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: 03/31/2019
• Device Catalogue Number: 1505291
• Device Lot Number: HA171036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1