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

Catalog Number	4236
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that paramedics drew up medication on two separate incidents and noticed fluid behind the plunger.There was a patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 07-nov-2024.Investigation summary: one presentation box containing thirteen unopened packages of product # 4236 lot # 4107232 was received for evaluation.The product used at the time of the complaint was not returned.Visual inspection of the provided samples did not reveal any defects or anomalies.All returned needles and needle-pro devices were found to be assembled within the packages prior to opening.The report stated that "syringes have been leaking out of the plunger." to evaluate the customers complaint, the returned samples were tested for leakage past the plunger.Prior to testing, the needle-pro was tightened to the syringe and needle to the pro, using a push and a slight twist and the caps manually removed.Results: leakage past the plunger was observed among three products, thus complaint confirmation.The syringe (10022604-001) is a supplied item which is purchased as an assembled product (syringe barrel, plunger, and plunger tip rubber).Inadequate manufacturing from the supplier is the root cause of this issue.The complaint information has previously been shared with the manufacturer and a snn was issued to them.Icu has not purchased this assembly since 2022.At this time, no further actions will be taken.Complaint information will continue to be monitored for any new information and further actions taken accordingly.Product number 4236 lot # 4107232 (38,400 pcs) was packaged 03-feb-21 on t-9.Dhr review found no discrepancies or anomalies relevant to the complaint.

• 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 Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20515711
• Report Number: 1217052-2024-00153
• Device Sequence Number: 12892737
• Product Code: FMI
• UDI-Device Identifier: 20351688048827
• UDI-Public: (01)20351688048827(17)260126(10)4107232
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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 Expiration Date: 01/26/2026
• Device Catalogue Number: 4236
• Device Lot Number: 4107232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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