MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305156
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	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd precision glide¿ needle had a substance on it.The following was received from the initial reporter: verbatim: customer observed a whitish substance on a bd brand 22g 1½ inch needle when opening it.I have attached a photo of the needle and its packaging.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: it was reported there was a whitish substance on the needle.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a needle with no plastic shield and white epoxy on the top part of the needle.The second photo shows a packaging blister next to a needle assembly.The needle assembly has the plastic shield.No other defects or imperfections were observed.The epoxy on the needle 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 epoxy drip over.A device history record review was completed for provided material number 305156, lot 1301669.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.Verification of the cannulator was performed.The settings were correct, and the flow of product was good.The sample will be shown to associate for awareness.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.
Event or Problem Description
It was reported that the bd precisionglide¿ needle had a substance on it.The following was recieved from the initial reporter: verbatim: customer observed a whitish substance on a bd brand 22g 1½ inch needle when opening it.I have attached a photo of the needle and its packaging.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17221824
• Report Number: 1911916-2023-00441
• Device Sequence Number: 7090782
• Product Code: FMI
• UDI-Device Identifier: 00382903051564
• UDI-Public: 00382903051564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 305156
• Device Lot Number: 1301669
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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