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

Model Number	96004
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: device evaluation: four unopened device packages for product: 96004, lot: aj220702 were received.The used device(s) were not returned for evaluation, but pictures were provided.The photos identified #aj220401 as the alleged defective lot, but samples from this batch were not provided for assessment.It could not be determined what saf-t wing blood collection set was used in conjunction with the saf-t holder.Visual inspection of the devices did not reveal any defects or anomalies.Functional testing for the provided devices were conducted.No discernible affects were noted.The returned samples functioned as intended without damage or cracks noted.Based on the results of this investigation, the complaint could not be confirmed with the samples provided.Therefore, no further actions will be taken at this time.A possible explanation for the observed issue may be from not following the instructions for use (ifu) procedures.The ifu outline a potential blood loss when collecting the first tube sample.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during receipt of the fully assembled products, to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that the rn accessed an iv with a device, attached 1 edta (ethylenediamine tetraacetic acid) tube which filled.Removed edta tube and blood continued to flow out of the iv, filling the hub and dripping on the floor.No adverse effects have been reported.

• Brand Name: JELCO SAF-T HOLDER MULTI SAMPLE LUER ADAPTER
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17317764
• Report Number: 3012307300-2023-07178
• Device Sequence Number: 15009121
• Product Code: JKA
• UDI-Device Identifier: 00351688065585
• UDI-Public: 00351688065585
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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 Model Number: 96004
• Device Catalogue Number: 96004
• Device Lot Number: AJ220401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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