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

Model Number	305110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd implemented a thorough investigation following our corrective preventative action protocol.This was opened for a trend in reports of ¿needle clogged / blocked¿, ¿aspirate / draw (cannot / difficult)¿, and ¿needle bent¿.All three of these issues have the same net effect: temporary interruption of flow of insulin into the reservoir.Based on the investigation, these issues appear to be related to the use case which involves drawing insulin from a vial into a syringe and then filling the reservoir of the insulin pump via a small port off the body in an iterative process, utilizing existing / ¿off the shelf¿ products rather than a product designed for this use.Bd products are designed to be single use, and because this is an "off the shelf" product, bd specifications do not take into account any requirements specific to the tandem use case.The investigation concludes the complaints are related to the use case and not due to a product nonconformance.
Event or Problem Description
It was reported that the bd precisionglide¿ needle experienced leakage.The following information was provided by the initial reporter: caller reported that when he attempted to fill his cartridge with insulin his cartridge began to leak.Customer reported using a new needle to fill cartridge.Number of occurrences - 1.Did issue cause any injury? - no.Did customer require medical intervention? - no.Resolution ¿ caller successfully filled a cartridge with insulin.No further tandem follow up is required.

• 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 ; 8015296192
• MDR Report Key: 15619703
• Report Number: 2124514-2022-00001
• Device Sequence Number: 5979437
• Product Code: FMI
• UDI-Device Identifier: 30382903051107
• UDI-Public: 30382903051107
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 10/11/2022

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: Lay User/Patient
• Device Model Number: 305110
• Device Catalogue Number: 305110
• Device Lot Number: UNKNOWN
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male