MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328411
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
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 that the bd insulin syringes with bd ultra-fine¿ needle experienced a mix of product types.The following information was provided by the initial reporter: customer stated that some of the needles appear to be a different length and will not fit into the vial.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-jan-2023 h6: investigation summary customer returned a 1ml, 30 gauge, 12.7mm syringe from lot 2017358.An additional 1ml syringe was returned, but featured a 6mm needle and was reported as being found in the same box of the 12.7mm syringes.The returned 12.7mm syringe was inspected.The needle point is curved backwards, though this damage may be the result of accidentally high stresses applied to the needle tip prior to or during use.Debris present is also believed to be from use.Flour was applied to the needle cannula and sufficient lubricant was found on the needle.Some warping was found at the base of the needle though this may have happened in tandem with the damage to the needle tip.No other damage to the syringe was observed.A review of the device history record was completed for batch# 2017358.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples received, embecta found damage to the tip of the syringe needle that may have occurred during use.The potential root cause of the damage to the needle tip may be stresses accidentally applied during use.
Event or Problem Description
It was reported that the bd insulin syringes with bd ultra-fine¿ needle experienced a mix of product types.The following information was provided by the initial reporter: customer stated that some of the needles appear to be a different length and will not fit into the vial.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15912105
• Report Number: 1920898-2022-00838
• Device Sequence Number: 5361552
• Product Code: FMI
• UDI-Device Identifier: 50382903284110
• UDI-Public: 00382908411035
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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 Model Number: 328411
• Device Catalogue Number: 328411
• Device Lot Number: 2017358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 12/03/2022
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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