MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE; SYRINGE, ANTISTICK

Model Number	4429-1
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a customer states the even numbers graduation marks quality is slanted causing concern from the clinicians on dosing.No adverse patient effects were reported.
Additional Manufacturer Narrative
H10- device evaluation results: visual inspection found that the graduation marks, located to the left of the barrel axis (corresponding to 5, 15, 25, 35, 45, 55, 65, 75, 85, 95 units of heparin) were skewed, not perpendicular to the barrel axis, thus confirming the customer reported product problem.A manufacturing problem was identified as the root cause.The provided samples were further evaluated for zero line registration and print orientation by using in-process test methods.While the samples passed the optical evaluation for zero line, they did not meet the tolerances of the print orientation gage.The water was drawn into each syringe by pushing the syringe plunger all the way down, putting the needle into the beak with water and drawing the water by lining up the top ring (front wiper seal) of the plunger tip with the desired mark on the syringe (i.E.5, 25, 45 and 100 units of insulin).The weight of the water volumes for each draw and sample was obtained in grams by using the scale and subtracting the weight of the dry syringe from the total weight of the syringe, containing the water.The obtained water volumes in grams were then compared to graduated capacity ranges, established based on tolerances on graduated.The obtained water volumes met the iso tolerances on graduated capacity of insulin syringes.The source of the problem is associated with the fns barrel printer set/up and/or adjustments.A non-conforming event was initiated to further evaluate and investigate the reported problem and determine further actions.A one year complaint history review since december 2019 identified no trends for this product and category.The production teams were notified for awareness of the problem reported in this complaint.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.
Additional Manufacturer Narrative
Other text: additional information: h3, h6, h7, h9.D5 is unknown.No information has been provided to date.Device evaluation: samples were provided for investigation.Visual inspection found that the graduation marks, located to the left of the barrel axis (corresponding to 5, 15, 25, 35, 45, 55, 65, 75, 85, 95 units of heparin) were skewed, not perpendicular to the barrel axis, thus confirming the customer reported product problem.A manufacturing problem was identified as the root cause.The provided samples were further evaluated for zero line registration and print orientation by using in-process test methods.While the samples passed the optical evaluation for zero line, they did not meet the tolerances of the print orientation gage.The water was drawn into each syringe by pushing the syringe plunger all the way down, putting the needle into the beak with water and drawing the water by lining up the top ring (front wiper seal) of the plunger tip with the desired mark on the syringe (i.E.5, 25, 45 and 100 units of insulin).The weight of the water volumes for each draw and sample was obtained in grams by using the scale and subtracting the weight of the dry syringe from the total weight of the syringe, containing the water.The obtained water volumes in grams were then compared to graduated capacity ranges, established based on tolerances on graduated.The obtained water volumes met the international organization for standardization (iso) tolerances on graduated capacity of insulin syringes.A non-conforming event was initiated to further evaluate and investigate the reported problem and determine further actions.A one year complaint history review since december 2019 identified no trends for this product and category.The production teams were notified for awareness of the problem reported in this complaint.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
• 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: 11129386
• Report Number: 3012307300-2021-00172
• Device Sequence Number: 11491823
• Product Code: MEG
• UDI-Device Identifier: 00351688060948
• UDI-Public: 00351688060948
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Type of Report: Initial,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
• Device Expiration Date: 09/15/2025
• Device Model Number: 4429-1
• Device Catalogue Number: 4429-1
• Device Lot Number: 4043536
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 07/21/2022
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/08/2021; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown