MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO NEEDLE EDGE SYRINGE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	432015
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: month and year of event have been provided, but day is unknown.The affected device was received for evaluation.Under magnification and cracks could be detected along the syringe barrels.To evaluate whether these defects would affect the syringe's functionality, a combo leak test was conducted.The customer's reported, problem was confirmed.It cannot be stated, with any certainty if the barrel had been flawed prior or following the assembly process.A root cause could not be determined.As a precaution, a quality alert was issued to the manufacturing floor.A review of the device history record (dhr) shows, there were no observations or nonconformities recorded, during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported, that the syringe was cracked and scratched.There was no patient involvement.And no patient harm reported.

• Brand Name: JELCO NEEDLE EDGE SYRINGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19962268
• Report Number: 1217052-2024-00075
• Device Sequence Number: 21049650
• Product Code: FMI
• UDI-Device Identifier: 00351688070992
• UDI-Public: (01)00351688070992(17)290325(10)6004734
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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: 432015
• Device Lot Number: 6004734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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