MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML HEPARIN 100 UNIT; HEPARIN VASCULAR ACCESS FLUSH

Model Number	306423
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported that the solution has a deep yellow color and black particles floating inside.To aid in the investigation, one sample in a sealed packaging flow wrap was received for evaluation by our quality team.The solution appears yellowish in color.A visual inspection was performed with a 10x magnifier lens.No loose foreign matter was observed.A laboratory test was performed and it confirmed that the discoloration was induced by a defective rubber stopper.A device history record review was completed for provided material number 306423, lot number 026683n.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.The sample will be sent to the stopper vendor for further analysis.Based on the investigation and with the 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.
Event or Problem Description
It was reported that the syringe 3ml heparin 100 unit solution was a "deep yellow" instead of clear, and black foreign particles were seen floating in it.The following information was provided by the initial reporter: "customer called and stated that the syringe is a deep yellow color, when it's usually clear, and there are black particles floating inside.".

• Brand Name: SYRINGE 3ML HEPARIN 100 UNIT
• 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: 11853530
• Report Number: 1911916-2021-00465
• Device Sequence Number: 19878957
• Product Code: NZW
• UDI-Device Identifier: 30382903064237
• UDI-Public: 30382903064237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/10/2021

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: 09/30/2022
• Device Model Number: 306423
• Device Catalogue Number: 306423
• Device Lot Number: 026683N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1