MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PLASTIC LOSS OF RESISTANCE SYRINGES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL

Model Number	4900
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lor syringe included in the pain trays are catching/sticking.There was no patient injury.
Additional Manufacturer Narrative
Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two (2) product samples were received for evaluation.Visual and functional testing were performed.Visual inspection found no defects or anomalies.Functional testing performed by the plunger was moved back and forth in the barrel and was rotated while holding the plunger end.Results: no leakage was observed, both syringe samples passed the loss of resistance (l.O.R) test.Devices passed all functional testing.No problem found.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-10927.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: PORTEX PLASTIC LOSS OF RESISTANCE SYRINGES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL
• 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; east bldg; minneapolis, MN 55442
• MDR Report Key: 14620879
• Report Number: 3012307300-2022-10927
• Device Sequence Number: 5014197
• Product Code: JKA
• UDI-Device Identifier: 20351688028065
• UDI-Public: 20351688028065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2023

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: 08/31/2024
• Device Model Number: 4900
• Device Catalogue Number: 4900
• Device Lot Number: 4214228
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 05/01/2023
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/26/2022; 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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