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

Model Number	192-N2558S
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 bd safetyglide¿ needles clogged.The following information was provided by the initial reporter: when they are adding safety needle to pre drawn syringe they are unable to remove the air, nothing comes out of needle, there is too much pressure.
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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1244726.Medical device expiration date: 31-aug-2026.Device manufacture date: 01-sep-2021.Medical device lot #: 2005672.Medical device expiration date: 31-dec-2026.Device manufacture date: 05-jan-2022.Medical device lot #: 1180363.Medical device expiration date: 31-may-2026.Device manufacture date: 29-jun-2021.
Event or Problem Description
It was reported that 3 bd safetyglide¿ needles clogged.The following information was provided by the initial reporter: when they are adding safety needle to pre drawn syringe they are unable to remove the air, nothing comes out of needle, there is too much pressure.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval? yes.D.9.Returned to manufacturer on: 06-oct-2022.H.6.Investigation summary: thirty four sealed samples and three photos were provided to our quality team for investigation.Upon photo evaluation, it was observed that the needle is bent and pulled out of the its hub.Physical samples visual inspection was performed with 30x microscope.No damage, defective grind or hooks were observed.The bevels and etch were good.Each sample was connected to a syringe with saline solution.All samples expelled the solution with normal flow.Furthermore, a device history record review was completed for provided lot numbers: 1244726, 2005672 and 1180363.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defects.Based on the investigation with the sample analysis the symptoms reported could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 15442014
• Report Number: 1213809-2022-00582
• Device Sequence Number: 14848381
• Product Code: FMI
• UDI-Device Identifier: 10612479248561
• UDI-Public: 10612479248561
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/03/2022

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-N2558S
• Device Catalogue Number: 306609
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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