MAUDE Adverse Event Report: WESTMED LLC ATELLICA® VTR SYRINGES; 3ML VENTED, LUER LOCK SYRINGE, 22G X 1" SAFETYTIP¿, 50 IU (~16.7 IU/ML) BALANCED

Model Number	11561350
Medical Device Problem Codes	Fail-Safe Problem (2936); Protective Measures Problem (3015)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: syringe.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause has not been determined all information reasonably known as of 14nov2024 has been included in this healh authority report.Should additional informaiton be obtained, a follow-up health authority report will be provided.The information provided by sunmed holdings llc., represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc., has not independing knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings complaint database and identified as (b)(6).This informaiton is submitted pursuant to 21cfr803, in complians with the medical device reporting requirement and should not be considered to be an admission that a sunmed holdings llc., product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc., received a single report that referenced two different incidences, which were associated with seperate units, involving the same nurse.This is the first report of two reports.Refer to 2028807-2024-00052.It was reported a fault in the needle's anti-pricking safety system.Although the anti-pricking system was activated, the tip of the needle remained exposed, resulting in the accidental pricking of a nurse, no patent was involved or impacted.
Additional Manufacturer Narrative
H6: syringe.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause has not been determined.All information reasonably known as of 14nov2024 has been included in this healht authority report.Should additional informaiton be obtained, a follow-up health authority report will be provided.The information provided by sunmed holdings llc., represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc., has not independing knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings complaint database and identified as (b)(4).This informaiton is submitted pursuant to 21cfr803, in complians with the medical device reporting requirement and should not be considered to be an admission that a sunmed holdings llc., product is defective or caused serious injury.The complaint of "a fault in the needle's anti-pricking safety system" regarding part 11561350 was not confirmed.The root cause could possibly be a result of an inadequately designed needle protection system.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.There have been 2 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Sunmed holdings llc., received a single report that referenced two different incidences, which were associated with seperate units, involving the same nurse.This is the first report of two reports.Refer to 2028807-2024-00052.It was reported a fault in the needle's anti-pricking safety system.Although the anti-pricking system was activated, the tip of the needle remained exposed, resulting in the accidental pricking of a nurse, no patent was involved or impacted.

• Brand Name: ATELLICA® VTR SYRINGES
• Common Device Name: 3ML VENTED, LUER LOCK SYRINGE, 22G X 1" SAFETYTIP¿, 50 IU (~16.7 IU/ML) BALANCED
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20690001
• Report Number: 2028807-2024-00044
• Device Sequence Number: 15628561
• Product Code: CBT
• UDI-Device Identifier: 10889483479483
• UDI-Public: (01)10889483479483
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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 Model Number: 11561350
• Device Catalogue Number: 11561350
• Device Lot Number: UNKNOWN
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown