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); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: device evaluation: one opened package and two photos were provided for investigation.The photos show a broken collar on a used device; a non icu medical luer connector iv pigtail is also seen in the photos.The actual device was not returned for investigation.Visual inspection of the provided sample revealed that the luer fitting was chipped, and a portion of the locking collar (which surrounds the luer) was broken off.The broken portion was not returned.The condition of the sample did not allow for testing to be conducted.A possible explanation for the observed issue maybe from not following the instructions for use (ifu) procedure.The ifu advises against using the device as a direct draw, and instructs the user to use a blood collection set.The damage observed with the provided saf-t holder seemed to suggest that a sideways force may have been inadvertently applied as the luer was either being connected to, or while attempting to remove it from an undetermined connection.It is also possible that a larger size 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 returned saf-t holder, blood culture device.It is feasible that this interaction may have contributed to the issue observed by the customer.Although the complaint was confirmed it cannot be determined how the luer breakage occurred.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.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.
Event or Problem Description
It was reported that the "end part broke off".Significant blood leakage occurred.There was no patient harm, injury, or adverse effects.

• 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: 17317756
• Report Number: 3012307300-2023-07176
• Device Sequence Number: 14976319
• Product Code: JKA
• UDI-Device Identifier: 00351688065585
• UDI-Public: 00351688065585
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: AJ220701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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