MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE 1 1/2 IN. THIN WALL, SINGLE USE, STERILE, 19 G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305187
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	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd¿ needle 1 1/2 in.Thin wall, single use, sterile, 19 g had epoxy on the needle.The following information was provided by the initial reporter: ¿i am writing to inform you that we have noticed unexpected white specks on the needles used for sterile compounding.".
Additional Manufacturer Narrative
H.6.Investigation: it was reported white specs were noticed on the needles.To aid in the investigation, six samples in opened packaging blisters and one photo was provided for evaluation by our quality team.A visual inspection was performed.The samples have the plastic shield and three of the six samples have an epoxy drip over.The other three do not.No other defects or imperfections were observed.The photo provided shows three of the sample received.This defect could occur during the assembly process.During manufacturing, the plastic hub is placed under the cannulator, then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it.After, a plastic shield is assembled.In this case, a jam may have occurred at the cannulator inducing the white epoxy drip over on the needle.A device history record review was completed for provided material number 305187, lot number 1225509.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 cannulator was performed.The settings were correct the flow of product was good.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 is confirmed.
Event or Problem Description
It was reported bd¿ needle 1 1/2 in.Thin wall, single use, sterile, 19 g had epoxy on the needle.The following information was provided by the initial reporter: ¿i am writing to inform you that we have noticed unexpected white specks on the needles used for sterile compounding.".

• Brand Name: BD¿ NEEDLE 1 1/2 IN. THIN WALL, SINGLE USE, STERILE, 19 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: 13385797
• Report Number: 1911916-2022-00028
• Device Sequence Number: 16572956
• Product Code: FMI
• UDI-Device Identifier: 30382903051879
• UDI-Public: 30382903051879
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 02/07/2022

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: 07/31/2026
• Device Model Number: 305187
• Device Catalogue Number: 305187
• Device Lot Number: 1225509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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