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

Catalog Number 1503278

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

It was reported that after the syringe was inserted into the thrombin vial the vials cap rubber was ¿coring¿ and the tip dropped into the vial bottle.This occurred during set-up.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).A calcium chloride vial and a needle syringe were received for evaluation.Visual inspection revealed a piece of orange material inside the needle syringe.In addition, a puncture was noted on the top of the rubber stopper.Further microscopic inspection revealed a clear cut and a tear on top of the rubber stopper.The reported condition was verified.The cause of the condition was not determined.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: 4947377
• MDR Text Key: 6035722
• Report Number: 1416980-2015-30501
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1503278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• 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