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

Model Number	192-N231S
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
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 safetyglide needle was clogged.The following information was provided by the initial reporter: during administration of vaccine received resistance from needle.
Additional Manufacturer Narrative
H6: investigation summary it was reported there was resistance from the needle while trying to administer a vaccine.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a needle assembly with no plastic shield.The safety mechanism has not been activated.No other information could be obtained from the photos.A device history record review was completed for provided material number 306610, lot number 2097348.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2097348 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the physical sample analysis, a probable root cause could not be offered.H3 other text : see h10.
Event or Problem Description
It was reported that the bd safetyglide needle was clogged.The following information was provided by the initial reporter: during administration of vaccine received resistance from needle.

• Brand Name: BD SAFETYGLIDE NEEDLE
• 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 ; 8015296192
• MDR Report Key: 15924305
• Report Number: 1213809-2022-01172
• Device Sequence Number: 5258742
• Product Code: FMI
• UDI-Device Identifier: 40612479248814
• UDI-Public: 10612479248554
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 12/13/2022

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: Other
• Device Model Number: 192-N231S
• Device Catalogue Number: 306610
• Device Lot Number: 2097348
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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: Unknown