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

Catalog Number	305900
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd safetyglide¿ safety needles, the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: incident details: when attempting intramuscular injection to the left deltoid, increased pressure was encountered and the injection attempt had to be abandoned, despite troubleshooting needle positioning, hub connection, etc.The patient had to receive a second intramuscular puncture with a new needle to a different site.Later troubleshooting with a new syringe (water filled) and the original needle (safety engaged, over appropriate receptacle) revealed the same initial elevation in pressure that was able to be overcome with considerable force.Another attempt with air filled syringe revealed increased pressure, though able to expel the air.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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
H6: investigation summary the defect is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h10.
Event or Problem Description
It was reported while using bd safetyglide¿ safety needles the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: incident details: when attempting intramuscular injection to the left deltoid, increased pressure was encountered and the injection attempt had to be abandoned, despite troubleshooting needle positioning, hub connection, etc.The patient had to receive a second intramuscular puncture with a new needle to a different site.Later troubleshooting with a new syringe (water filled) and the original needle (safety engaged, over appropriate receptacle) revealed the same initial elevation in pressure that was able to be overcome with considerable force.Another attempt with air filled syringe revealed increased pressure, though able to expel the air.

• Brand Name: BD SAFETYGLIDE¿ SAFETY NEEDLES
• 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: 16496478
• Report Number: 1213809-2023-00158
• Device Sequence Number: 6536474
• Product Code: FMI
• UDI-Device Identifier: 00382903059003
• UDI-Public: (01)00382903059003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 305900
• Device Lot Number: 9018983
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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