MAUDE Adverse Event Report: PRESSURE RATED EXT, IV CONNECTOR, NO CL; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ5305
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20075813.Medical device expiration date: 2023-07-23.Device manufacture date: 2020-07-06.Medical device lot #: 19105439.Medical device expiration date: 2022-10-04.Device manufacture date: 2019-10-03.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.".
Event or Problem Description
It was reported that a pressure rated ext, iv connector, no cl had foreign matter.The following was reported by the initial reporter: "during the preparation of the material for infusion of a patient, we noted the yellowish colour of the extension tube.This yellowish colour only appeared on the batch series indicated above.Clinical consequences observed : material not used to infuse the patient due to the unusual colour of the extension tube.".
Event or Problem Description
It was reported that a pressure rated ext, iv connector, no cl had foreign matter.The following was reported by the initial reporter: "during the preparation of the material for infusion of a patient, we noted the yellowish colour of the extension tube.This yellowish colour only appeared on the batch series indicated above.Clinical consequences observed : material not used to infuse the patient due to the unusual colour of the extension tube".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: (b)(6) 2021.H.6.Investigation: sixty-six mz5305 samples were received for investigation.Four samples were received in sealed packaging from lot 19105439 and sixty-two samples were received from lot 20075813, two in open packaging and sixty in sealed packaging.A visual inspection of the returned samples confirmed the customer's experience as the tubing was observed to be discoloured yellow.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records as well as the sterilization records for lot 19105439 and 20075813 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note that yellow discolouration of the tubing can typically occur after irradiation sterilisation and the degree of discolouration can change over time and under certain storage conditions.This type of discolouration does not however affect the functionality of the device and therefore is considered to be a cosmetic defect.

• Brand Name: PRESSURE RATED EXT, IV CONNECTOR, NO CL
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12162506
• Report Number: 9616066-2021-51503
• Device Sequence Number: 3713717
• Product Code: FPA
• UDI-Device Identifier: 50885403230583
• UDI-Public: 50885403230583
• 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): 07/23/2021

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 Expiration Date: 10/04/2022
• Device Model Number: MZ5305
• Device Catalogue Number: MZ5305
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1