MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS MULTI LINE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MBF27
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the device was leaking from luer lock port."cracks/shattering" of the male luer lock connector at the end.Patient involvement unknown.
Additional Manufacturer Narrative
B3: date of event, d4: lot number, expiration date.And h4: device manufacture date is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.
Event or Problem Description
Additional information was received confirming the item was broken during patient use, but patient was not harmed.There was a delay in therapy in order to swap out components due to broken line.No patient adverse effects reported.The reporter stated that these were the potential lot numbers: 4319536, 4215451, and 4340434.
Additional Manufacturer Narrative
Other text: d3, g1, and g2 email is: regulatory.Responses@icumed.Com.H6 - evaluation codes: updated.Device evaluation: no product sample or pictures were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX EXTENSION SETS MULTI LINE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17187064
• Report Number: 3012307300-2023-06562
• Device Sequence Number: 6391320
• Product Code: FPA
• UDI-Device Identifier: 10351688510471
• UDI-Public: 10351688510471
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K841882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2023

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: MBF27
• Device Catalogue Number: MBF27
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 11/08/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/27/2023; 12/14/2023
• 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