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

Catalog Number	305900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 pulled out of the hub while injecting cortisone into the shoulder joint.The following information was provided by the initial reporter: "the bd needle he was using for a shoulder joint injection detached from the needle hub during administration of cortisone." "needle became detached from needle hub while providing shoulder injection by physician.".
Additional Manufacturer Narrative
H6: investigation summary seven photos of a safetyglide 22 x 1 ½ inch needle (p/n 305900) batch 1176150 were received and evaluated.The pictures show the cannula separated from the hub with a small dot of clear glue-like substance on the cannula near where the cannula should be attached to the hub.The condition observed is non-conforming per product specifications.Potential root cause for cannula pulled out defect is associated with the needle supplier¿s manufacturing process.The photos were forwarded to the needle supplier for further evaluation and investigation.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Potential root cause for cannula pulled out defect is associated with assembly line.A jam may have occurred at the cannulator inducing the insufficient epoxy applied to the needle and not detected in the next processes.Verification of the cannulator was performed.The settings were correct and the flow of products was good.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.
Event or Problem Description
It was reported that the bd safetyglide¿ needle pulled out of the hub while injecting cortisone into the shoulder joint.The following information was provided by the initial reporter: "the bd needle he was using for a shoulder joint injection detached from the needle hub during administration of cortisone." "needle became detached from needle hub while providing shoulder injection by physician.".

• 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: 13977550
• Report Number: 1213809-2022-00172
• Device Sequence Number: 17502690
• Product Code: FMI
• UDI-Device Identifier: 00382903059003
• UDI-Public: 00382903059003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/20/2022

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: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 305900
• Device Lot Number: 1176150
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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 Age: 67 YR
• Patient Sex: Male