MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE ONLY; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305915
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Fever (1858)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Investigation summary: five samples and two photos were provided to our quality team for investigation.Through visual inspection, it was observed that five empty sealed packages missing the needle.Potential root cause for the empty package defect is associated with the packaging process.These conditions are occurring below their expected frequency so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 2258081.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h.10.
Event or Problem Description
It was reported while using bd safetyglide¿ needle only foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: one strip of 5 needles; package contained only air, no needles/caps.Package also contains black material (dust, worm, grease, unsure); primarily in one package, but also speckled throughout the other 4 attached packages.Product had been delivered to patient.Once discovered, she discarded the remainder of the box of 50 (~15 needles) patient's mother reports she had low grade fevers last week.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE ONLY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17283652
• Report Number: 1213809-2023-00710
• Device Sequence Number: 17688572
• Product Code: FMI
• UDI-Device Identifier: 30382903059158
• UDI-Public: (01)30382903059158
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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
• Report Date (Section B): 07/04/2023

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 Model Number: 305915
• Device Catalogue Number: 305915
• Device Lot Number: 2258081
• 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: 06/15/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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