MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 5ML HEPARIN; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number	306424
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that patient admitted to hospital due to sever thrombosis after being treated with a bd syringe 5ml heparin.The following information was provided by the initial reporter: customer called and stated that a patient was treated with a bd posiflush ((b)(6) 2019) has been admitted to the hospital today ((b)(6) 2019) with severe thrombosis leukaemia.Pt's platelets yesterday were normal and as at time of admission is 2.Customer has isolated remaining products from this lot and has representative samples to send.
Event or Problem Description
It was reported that patient admitted to hospital due to sever thrombosis after being treated with a bd syringe 5ml heparin.The following information was provided by the initial reporter: customer called and stated that a patient was treated with a bd posiflush ((b)(6) 2019) has been admitted to the hospital today ((b)(6) 2019) with severe thrombosis leukaemia.Pt's platelets yesterday were normal and as at time of admission is 2.Customer has isolated remaining products from this lot and has representative samples to send.
Additional Manufacturer Narrative
Investigation: five representative samples were received.They came in the sealed packaging flow wrap.They were sent to the laboratory for testing.Testing results were good and all sample passed.All our inspections and testing performed while manufacturing above listed batch were accepted.No rejections were documented.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD SYRINGE 5ML HEPARIN
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8832803
• Report Number: 1911916-2019-00735
• Device Sequence Number: 16903975
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 306424
• Device Lot Number: 836283N
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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