MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; TUBES, VIALS, SYSTEMS, BLOOD COLLECTION

Model Number	4900
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe lost resistance.No patient injury was reported.
Additional Manufacturer Narrative
Product samples from the same lot was received for evaluation.One non-original box containing 24 unopened original syringes was received from the reported lot number.However, the syringe sample used at the time of the complaint was not returned by the customer for investigation.Visual and functional testing were performed.All 24 syringes passed the lost of resistance test without issue.2 of the 24 samples, failed to have a frictional fit.The plungers of these two samples, were easily removed from the syringe barrels, indicating that the fit was not acceptable between the stop rings.Further investigation of the components dimensionally, revealed that the stop ring diameter of the syringe barrel was over specification.This allowed the plunger to be removed from the barrel too easily.All other components were found to be within specification.It is not clear from the complaint description if this was the type of issue that the customer had experienced.All other aspects of the syringes were found to be acceptable.The device history record (dhr) investigation revealed that one of the lots of the syringe barrels used to produce this product, had an issue with the stop ring diameter.A nonconformance report (ncr) was initiated by production.This prompted a supplier nonconformance notification (snn) to be issued by the supplier quality engineer.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX
• Common Device Name: TUBES, VIALS, SYSTEMS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15315998
• Report Number: 3012307300-2022-16601
• Device Sequence Number: 14924694
• Product Code: JKA
• UDI-Device Identifier: 20351688028065
• UDI-Public: 20351688028065
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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: 01/31/2023
• Device Model Number: 4900
• Device Catalogue Number: 4900
• Device Lot Number: 3960816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown