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

Catalog Number	305110
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that the bd precisionglide¿ needle cored the medication vial during use.The following information was provided by the initial reporter: " caller reported fill resistance issue.Did the caller insert the needle into the cartridge and encounter fill resistance? - yes with how many cartridges did the caller experience the issue? ¿ one was the syringe/needle reused? - no was the cartridge reused/refilled? - no.Customer's bg at time of event - [250 mg/dl] ; between 54-500 mg/dl (3.0-27.7 mmol/l).Does insulin come out of the existing needle? - no.Was caller able to fill the existing cartridge with the second needle? ¿ yes.Resolution ¿ caller successfully loaded existing cartridge with second needle.Additional info from phone call with customer: customer stated that they feel strongly that needle might be coring the vial".
Event or Problem Description
It was reported that the bd precisionglide¿ needle cored the medication vial during use.The following information was provided by the initial reporter: " caller reported fill resistance issue.Did the caller insert the needle into the cartridge and encounter fill resistance? -yes.With how many cartridges did the caller experience the issue? ¿ one.Was the syringe/needle reused? - no.Was the cartridge reused/refilled? - no.10) customer's bg at time of event - [250 mg/dl] ; between 54-500 mg/dl (3.0-27.7 mmol/l).Does insulin come out of the existing needle? - no.Was caller able to fill the existing cartridge with the second needle? ¿ yes.Resolution ¿ caller successfully loaded existing cartridge with second needle.Additional info from phone call with customer: customer stated that they feel strongly that needle might be coring the vial.".
Additional Manufacturer Narrative
H6: investigation summary: it was reported the needle is clogged from possible coring of the vial.To aid in the investigation, one sample with no plastic shield and a bd top web from lot 0051124 was received for evaluation by our quality team.A visual inspection was performed with 10x magnification, and it was confirmed the needle returned is not a bd needle.No further analysis was performed.A device history record review was completed for provided material number 305110 lot 0051124.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.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.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16710506
• Report Number: 1911916-2023-00225
• Device Sequence Number: 15263193
• Product Code: FMI
• UDI-Device Identifier: 00382903051106
• UDI-Public: 00382903051106
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 305110
• Device Lot Number: 0051124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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 Age: 42 YR
• Patient Sex: Female