MAUDE Adverse Event Report: NULL JELCO HYPODERMIC NEEDLES; NEEDLE, SPINAL, SHORT TERM

Catalog Number 182025

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the customer noticed the needle was drawn back a little more inside the syringe than normal.No patient involvement.No additional information is available for this complaint.

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: 3012307300-2022-04204.The report was submitted in error.

• Brand Name: JELCO HYPODERMIC NEEDLES
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section G): NULL
• MDR Report Key: 13623942
• MDR Text Key: 286373927
• Report Number: 3012307300-2022-04204
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 182025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2670-2017
• Patient Sequence Number: 1