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

Model Number	4291
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when aspirating the syringe, bubbles of air were aspirated.The needle was withdrawn from the skin to check and it was observed that a few mls of air were now in the syringe.It was also noticed needle did appear very flexible as it was excessively bending when the safety cover was being applied.No other information known.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history review.Evaluation of the provided sample was completed with unaided eye and found a small gauge hypodermic needle.The cannula was engaged and the needle cap was separate in the bag.Per complaints details, the actual needle was disposed of by the customer.The syringe used by the customer was not returned for evaluation.The cannula of the returned needle appeared to be fully engaged into the needle protection sheath and did not pose any risk of a needle stick.No visible non-conformities were present on the device.As per the instructions for use, that is provided with product, it warns the user that mishandling of the needle protection device may cause needles, especially short or small gauge needles, to bend whereby they protrude from the needle protector sheath which may result in a contaminated needle stick.It is not clear from the complaint description what type of syringe was used with the needle and what type of fluid was aspirated into the syringe.Depending on the product application a different (larger gauge) size needle may be chosen as well as a different syringe may be utilized (such as vented syringes) to successfully complete the procedure.Based on available evidence, the reported problem could not be verified.No action taken.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history review.Evaluation of the provided sample was completed with unaided eye and found a small gauge hypodermic needle.The cannula was engaged and the needle cap was separate in the bag.Per complaints details, the actual needle was disposed of by the customer.The syringe used by the customer was not returned for evaluation.The cannula of the returned needle appeared to be fully engaged into the needle protection sheath and did not pose any risk of a needle stick.No visible non-conformities were present on the device.As per the instructions for use, that is provided with product, it warns the user that mishandling of the needle protection device may cause needles, especially short or small gauge needles, to bend whereby they protrude from the needle protector sheath which may result in a contaminated needle stick.It is not clear from the complaint description what type of syringe was used with the needle and what type of fluid was aspirated into the syringe.Depending on the product application a different (larger gauge) size needle may be chosen as well as a different syringe may be utilized (such as vented syringes) to successfully complete the procedure.Based on available evidence, the reported problem could not be verified.No action taken.

• Brand Name: JELCO HYPODERMIC NEEDLE
• 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: 13282853
• Report Number: 3012307300-2022-00999
• Device Sequence Number: 12004185
• Product Code: FMI
• UDI-Device Identifier: 20351688046816
• UDI-Public: 20351688046816
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: 08/06/2026
• Device Model Number: 4291
• Device Catalogue Number: 4291
• Device Lot Number: 4135446
• 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: 12/30/2021
• Supplement Date Received by Manufacturer: 05/02/2023; 05/02/2023
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 06/05/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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