MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAF-T HOLDER DEVICES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD CO

Model Number	96004
Medical Device Problem Code	Break (1069)
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 customer was having issues with a broken distal port.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review for this lot found no issues relevant to the complaint.The device was received for evaluation.Visual inspection of the device revealed that the luer fitting and a portion of the locking collar (which surrounds the luer) appeared to have been broken off.The broken portion(s) was not returned for investigation.The damage observed suggest that a sideway force may have been inadvertently applied, as the luer was either being connected to or while attempting to remove the device from an undetermined connection.It is also possible that the larger size of a blood culture vacuum tube/bottle may have acted as a leverage fulcrum point.It is not known what device or connection was used in conjunction with the device by the customer at the time of the complaint.It is feasible that this interaction may have contributed to the issue that was observed by the customer.While this type of damage to the device has been identified as a complaint pattern, the root cause has not yet been determined with any certainty.This complaint pattern has been conveyed to the appropriate personnel to initiate further examination.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 b10009406, as a result of warning letter cms# 617147.

• Brand Name: JELCO SAF-T HOLDER DEVICES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD CO
• 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: 15397859
• Report Number: 3012307300-2022-18546
• Device Sequence Number: 5057251
• Product Code: JKA
• UDI-Device Identifier: 00351688065585
• UDI-Public: 00351688065585
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K923090
• 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): 09/11/2022

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: Health Professional
• Device Expiration Date: 12/16/2024
• Device Model Number: 96004
• Device Catalogue Number: 96004
• Device Lot Number: AJ191204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• 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