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

Model Number	4429-1
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Quality defect, the barrel markings are askew on the barrel of the syringe.The even numbers on the scale are squarely aligned but the odd numbers are skewed approximately 20 degrees upward.Concerned that the customer would reject the lot fear of miss-dosing patients.No patient involvement.
Additional Manufacturer Narrative
H10- device evaluation results: evaluation of the provided samples with unaided eye found that all graduation marks, located to the left and to the right of the barrel axis, are perpendicular to the barrel axis.Although the numbers, located to the left from barrel axis may visually appear to be slightly angled, they were visibly legible and centered on the graduation marks.These numbers were observed to be close to, but not touching the ends of the graduation lines.The provided samples were further evaluated for zero line registration and print orientation by using in-process test methods.The syringes passed the optical evaluation for zero line and met the tolerances of the print orientation gage.The provided samples were found to be within established specification and met iso8537:2016 (e) requirements.Based on the evaluation of the provided evidences, the reported allegation could not be confirmed.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Additional Manufacturer Narrative
Other text: additional information: g3, h7, h9.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: JELCO
• Common Device Name: SYRINGE, ANTISTICK
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11144337
• Report Number: 3012307300-2021-00231
• Device Sequence Number: 631995
• Product Code: MEG
• UDI-Device Identifier: 00351688060948
• UDI-Public: 00351688060948
• Combination Product (Y/N): N
• PMA/510(K) Number: K063755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2022

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: Other
• Device Expiration Date: 07/13/2025
• Device Model Number: 4429-1
• Device Catalogue Number: 4429-1
• Device Lot Number: 4014096
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 07/10/2022; 07/10/2022
• Initial Report FDA Received Date: 01/10/2021
• Supplement Report FDA Received Date: 02/08/2021; 09/21/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1798-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown