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

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 while using bd posiflush¿ heparin lock flush syringe 2 different syringes did not have labels.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the customer found 2 syringes without labels.A nurse in the patient's home reported 2 unlabeled syringes.
Additional Manufacturer Narrative
It was reported the customer found two syringes without labels.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two syringes with no barrel label.No other defects or imperfections were observed.This defect could occur if there was a jam during the syringe barrel labeling process inducing the symptom reported.A device history record review was completed for provided material number 306424, lot number 131596n.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the syringe barrel labeling process was performed.The settings and alignment were correct, and the flow of products were good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Common Device Name: HEPARIN, 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 ; 8015296192
• MDR Report Key: 14564959
• Report Number: 1911916-2022-00276
• Device Sequence Number: 20069312
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K163591
• 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
• Report Date (Section B): 05/12/2022

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: Other
• 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: 05/04/2022
• Initial Report FDA Received Date: 06/01/2022
• 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