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

Model Number	96004
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nurse went to draw blood and was not able to draw.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.It could not be confirmed if a quality related issue had occurred during use of this device.No product device was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product device was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.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: JELCO BLOOD COLLECTION SAF-T HOLDER
• 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): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15552208
• Report Number: 3012307300-2022-21976
• Device Sequence Number: 6158683
• Product Code: JKA
• UDI-Device Identifier: 00351688065585
• UDI-Public: 00351688065585
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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: 09/04/2025
• Device Model Number: 96004
• Device Catalogue Number: 96004
• Device Lot Number: AJ200902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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