MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ TUBERCULIN SYRINGE; PISTON SYRINGE

Catalog Number	305945
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.E.4.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).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 the needle fell off the bd safetyglide¿ tuberculin syringe when attempting to engage the needle cap during use.The following information was provided by the initial reporter: "describe the event or problem: after injection, the registered nurse went to engage the needle cap cover with her index finger and as she pushed the cover device fell off (complete disconnection from syringe).No harm to staff or patient.".
Event or Problem Description
Mat# 305945.Lot# 2221003a1.It was reported by the customer that after injection, the registered nurse went to engage the needle cap cover with her index finger and as she pushed the cover device fell off (complete disconnection from syringe).No harm to staff or patient.(b)(4).Lot# 2221003a1 (not able to find in sap) event title: no event title provided describe the event or problem: after injection, the registered nurse went to engage the needle cap cover with her index finger and as she pushed the cover device fell off (complete disconnection from syringe).No harm to staff or patient.What problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do; additional info received on 31mar2023 were you able to correct the issue using another needle? based on information known at this time, the medication had already been administered and the protective cap fell off when the nurse attempted to engage the device.No other device was needed.
Additional Manufacturer Narrative
Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.

• Brand Name: BD SAFETYGLIDE¿ TUBERCULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16740582
• Report Number: 1920898-2023-00224
• Device Sequence Number: 15130931
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: 00382903059454
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 03/13/2024

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 Catalogue Number: 305945
• Device Lot Number: 2221003
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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 Age: 83 YR
• Patient Sex: Unknown