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

Model Number	4290
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical sharps safety|jelco hypodermic needle-pro needles leaked medication.Reported after the nurse administered im epinephrine, it was noted that the needle had a hole and leak was observed on the patients skin.The medication was critical for the patient experiencing a severe allergic reaction as anterior, expiratory and inspiratory wheezing was noted along with intercostal retractions.Intravenous medication was resorted to then.The incident was given a stat priority following the failed intramuscular injection, as the patient was in distributive shock.Patient was reported to improve after receiving the intravenous route of administration.
Additional Manufacturer Narrative
Other, other text: the product was assembled and packaged 17-nov-20 on t-7 (168,000).Dhr review found no discrepancies or anomalies relevant to the complaint.Incoming records review for needle component ne482 (lot #'s 20i03-4, 20i07-4) and for pro component mp836 (lot # 83530305) found no issues relevant to the complaint.No product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.
Event or Problem Description
Investigation completed.No product was returned, attached in sme summary.

• Brand Name: JELCO
• Common Device Name: HYPODERMIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11624914
• Report Number: 3012307300-2021-02885
• Device Sequence Number: 3291824
• Product Code: FMI
• UDI-Device Identifier: 20351688046823
• UDI-Public: 20351688046823
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2025
• Device Model Number: 4290
• Device Catalogue Number: 4290
• Device Lot Number: 4073942
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 5 YR