MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE 18 G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305181
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Investigation summary: it was reported the medication turned a light orange color when drawing up with the needle.To aid in the investigation, three hundred thirty-two samples and three photos were provided for evaluation by our quality team.Three hundred thirty-one samples came in sealed packaging blisters and one sample came in an opened packaging blister.A visual inspection was performed with a 10x magnifier lens and there was no foreign matter of any type observed.The three photos provided show a needle assembly next to two vials, one syringe and two needle assemblies one next to the other.One needle assembly has discoloration inside the needle hub.No other defects or imperfections were observed.A device history record review was completed for provided material number 305181, lot number 1335567.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.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.
Event or Problem Description
It was reported while using bd¿ blunt fill needle 18 g foreign matter was found and the medication became discolored.There was no report of patient impact.The following information was provided by the initial reporter: noticed that when the medication was drawn up, the medication turned a light orange color.The medication in the vial was initially clear.The inside of the blunt tip needle that she used to draw up the medication, there was a black material (almost looking like mold or ink of some sort).

• Brand Name: BD¿ BLUNT FILL NEEDLE 18 G
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 16213381
• Report Number: 1911916-2023-00007
• Device Sequence Number: 17228716
• Product Code: FMI
• UDI-Device Identifier: 00382903051816
• UDI-Public: (01)00382903051816
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 01/03/2023

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 Catalogue Number: 305181
• Device Lot Number: 1335567
• 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: 12/30/2022
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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