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

Catalog Number 1503278

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that rubber from a floseal thrombin was cored when the syringe was inserted.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection noted that there was particulate matter in the barrel of the syringe.The reported condition was verified.The cause of the particle is due to coring of the rubber stopper of the vial.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 - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer (Section G): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5276823
• MDR Text Key: 32995743
• Report Number: 1416980-2015-43720
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 1503278
• Device Lot Number: HA141140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1