MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETERS; BLOOD COLLECTION SAF-T HOLDER

Model Number	96004
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the sample was not received for investigation however; images were provided.The customer reported issue could not be confirmed due to no receipt of photos or actual sample for investigation.The images show the needless valve with remnants of the luer; thus confirming the complaint however; images do not allow for a thorough evaluation of the type and condition of the device that was used with the valve.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.The root cause for the reported issue could not be determined.If the product is returned at a later, a summary of the investigation results will be provided in a supplemental report.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that two components broke during normal use at the luer lock adapter leaving pieces embedded in the needle-less clave on the intravenous (iv) pigtail.There was no patient harm reported.

• Brand Name: JELCO SAFETY VIAVALVE CATHETERS
• Common Device Name: BLOOD COLLECTION SAF-T HOLDER
• 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: 15353771
• Report Number: 3012307300-2022-17608
• Device Sequence Number: 14958283
• Product Code: JKA
• UDI-Device Identifier: 00351688065585
• UDI-Public: 00351688065585
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2022

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 Model Number: 96004
• Device Catalogue Number: 96004
• Device Lot Number: AJ191103
• 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: 05/19/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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