MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306545
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 the bd posiflush¿ sp syringes were labeled as heparin syringes on the case.The following information was provided by the initial reporter: "wherever these are produced made the mistake, inside the cases labeled heparin are all saline flushes.The box that came in today¿s order cardboard was damaged a little and saw saline boxes inside of the cardboard labeled heparin.".
Event or Problem Description
It was reported that the bd posiflush¿ sp syringes were labeled as heparin syringes on the case.The following information was provided by the initial reporter: "wherever these are produced made the mistake, inside the cases labeled heparin are all saline flushes.The box that came in today¿s order cardboard was damaged a little and saw saline boxes inside of the cardboard labeled heparin.".
Additional Manufacturer Narrative
H6: investigation summary it was reported the cases labeled heparin are all saline flushes.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a case box for heparin products labeled for saline products.This defect could occur if the incorrect case boxes were used while producing the saline products.A device history record review was completed for provided material number 306545, lot 3004288.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• 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 ; 8448235433
• MDR Report Key: 16943012
• Report Number: 1911916-2023-00311
• Device Sequence Number: 6850508
• Product Code: NGT
• UDI-Device Identifier: 00382903065455
• UDI-Public: 00382903065455
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: Other
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 306545
• Device Lot Number: 3004288
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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