MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5ML; VASCULAR CATHETER FLUSH SYRINGE

Model Number	306424
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two 5 ml bd posiflush¿ heparin lock flush syringe, 500 usp units/5ml does not have the manufacturer label.The following information was provided by the initial reporter: patient received a sealed box of heparin 100u/ml flushes wherein 2 flushes had not manufacturer label.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The initial reporter also notified the fda on 05 may, 2022.Medwatch report # mw5109587.
Additional Manufacturer Narrative
This complaint has been determined to be a duplicate of mfr report# 1911916-2022-00276.The original submission, 1911916-2022-00311 can therefore be disregarded.
Event or Problem Description
It was reported that two 5 ml bd posiflush¿ heparin lock flush syringe, 500 usp units/5ml does not have the manufacturer label.The following information was provided by the initial reporter: patient received a sealed box of heparin 100u/ml flushes wherein 2 flushes had not manufacturer label.

• Brand Name: 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5ML
• Common Device Name: VASCULAR CATHETER FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14776761
• Report Number: 1911916-2022-00311
• Device Sequence Number: 5779887
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: 306424
• Device Catalogue Number: 306424
• Device Lot Number: 131596N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown