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

Model Number	EL31915
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the syringe is skewed resulting in improper needle attachment.No additional information.
Additional Manufacturer Narrative
Device evaluation: the device was returned for investigation.Visual inspection of the returned sample revealed that the luer fitting of one of the syringes (sy113), was bent.The sample was compared to the visual reference chart (fm0591, rev 100) which demonstrates the acceptable limit for a slightly bent syringe luer.Based on the tolerance criteria, the returned sample was found to be outside of the limit, thus confirming this complaint.To test the sample for leakage between mating luers, it was assembled according to ifu (as10011079-002, section 6.2), using a push and a clockwise twist.The assembled product was tested according to qtm\022-00-00, rev 004, combo leak test.Results: no leakage was observed between the mating luers (syringe, needle-pro and needle).The returned sample functioned as intended the customer stated problem was duplicated.The cause of the reported problem was traced to the manufacturing process.Dhr review found no discrepancies or anomalies relevant to the complaint.No non-conformities were noted.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-05885.The report was submitted in error.

• Brand Name: JELCO HYPODERMIC NEEDLE PRO NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14021487
• Report Number: 3012307300-2022-05885
• Device Sequence Number: 2632944
• Product Code: FMI
• UDI-Device Identifier: 00351688072545
• UDI-Public: 00351688072545
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2023

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: Health Professional
• Device Expiration Date: 07/13/2025
• Device Model Number: EL31915
• Device Catalogue Number: EL31915
• Device Lot Number: 4022472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 05/01/2023
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/25/2022; 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown