MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE ONLY, 21 G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305917
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use of the bd safetyglide¿ needle only, 21 g there was foreign matter on the needle.It was reported by the customer that she informed lot #: 2147696 product #: (b)(4), c#: (b)(4), ref#: (b)(4), imf#: 55222, 21g 1 ½, in safety glide needle with plastic particle on the needle.Third instance in ~3weeks (two found same day on (b)(6) 2023) where a plastic particle was noted on the tip or on the side of the needle upon uncapping the needle prior to administration of medication by provider.Contaminated needle with foreign body attached.Unsafe for patient use.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that before use of the bd safetyglide¿ needle only, 21 g there was foreign matter on the needle.It was reported by the customer that she informed lot #2147696 product # 305917: c#715573, ref#(b)(4) , imf#55222, 21g 1 ½, in safety glide needle with plastic particle on the needle.Third instance in ~3weeks (two found same day on (b)(6) 23) where a plastic particle was noted on the tip or on the side of the needle upon uncapping the needle prior to administration of medication by provider.Contaminated needle with foreign body attached.Unsafe for patient use.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE ONLY, 21 G
• 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: 16908346
• Report Number: 1213809-2023-00486
• Device Sequence Number: 5562110
• Product Code: FMI
• UDI-Device Identifier: 30382903059172
• UDI-Public: (01)30382903059172
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/14/2023

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: 305917
• Device Catalogue Number: 305917
• Device Lot Number: 2147696
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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