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

Catalog Number	305903
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
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 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 during use with 2 bd safetyglide¿ the plunger was difficult to move.There was no patient impact.The following information was provided by the initial reporter: pharmacist reporting on behalf of patient, 2 resistance pushing plunger harm or adverse events; none.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-jun-2023.H6: investigation summary: thirty-eight samples were provided to our quality team for investigation.The reported issues were not confirmed upon inspection of the samples.None of the samples showed any signs of the reported defects.Since the reported defect was not confirmed a manufacturing root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.H3 other text : see h10.
Event or Problem Description
It was reported that during use with 2 bd safetyglide¿ the plunger was difficult to move.There was no patient impact.The following information was provided by the initial reporter: pharmacist reporting on behalf of patient, 2 resistance pushing plunger harm or adverse events ; none.

• Brand Name: BD SAFETYGLIDE¿
• 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: 17121337
• Report Number: 1213809-2023-00644
• Device Sequence Number: 7038719
• Product Code: FMI
• UDI-Device Identifier: 00382903059034
• UDI-Public: 00382903059034
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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 Catalogue Number: 305903
• Device Lot Number: 2145507
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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