MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT MINIBORE QUAD-FSEE, 4IV CNNTRS.4CKVS; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9283
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.".
Event or Problem Description
It was reported that 1 ext minibore quad-fsee, 4iv cnntrs.4ckvs leaked during use.The following was reported by the initial reporter: "our resuscitation department reported 2 events with potentially serious consequences related to the 4-way connectors reference mz9283.Twice there was a leak in the amine pathway leading to patient failure.For the first report on january 21, 2001, it was noted that the thread was crooked.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-29 h6: investigation summary one mfx2514mp sample was received without packaging for investigation; residual fluid was present in the device (appendix 1).A visual inspection of the mfx2514mp sample did not identify signs of damage or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by flushing all the lines and by subjecting the sample to pressure testing; no leakage was identified throughout testing.Additionally the sample was subjected to air pressure testing whilst submerged under water; again no leakage was identified throughout testing.The details of this feedback were shared with the legal manufacturer of the product, impromediform gmbh for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.
Event or Problem Description
It was reported that 1 ext minibore quad-fsee, 4iv cnntrs.4ckvs leaked during use.The following was reported by the initial reporter: "our resuscitation department reported 2 events with potentially serious consequences related to the 4-way connectors reference mz9283.Twice there was a leak in the amine pathway leading to patient failure.For the first report on (b)(6), 2001, it was noted that the thread was crooked.".

• Brand Name: EXT MINIBORE QUAD-FSEE, 4IV CNNTRS.4CKVS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 11608844
• Report Number: 9616066-2021-50651
• Device Sequence Number: 14427777
• Product Code: FPA
• UDI-Device Identifier: 50885403230668
• UDI-Public: 50885403230668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: MZ9283
• Device Catalogue Number: MZ9283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1