MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MINIBORE BI-FUSE EXT, 2 IV CNNTR, 2CKV; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9279
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).
Event or Problem Description
It was reported that a minibore bi-fuse ext, 2 iv cnntr, 2ckv experienced component separation during use.The following was reported by the initial reporter: "the device is not properly welded in all its connecting parts.Specifically, the set that connects to the cvc, in the part of the conjunction of the two branches of the octopus, also detaches with not necessarily violent stresses.Unfortunately this happened to a little patient of ours during an infusion.Since this is an event that cannot and must absolutely not happen as it exposes you to the risk of even substantial bleeding (which is what happened in part), of possible infection and leakage of antiblastics, i consider it appropriate to report it immediately.".
Event or Problem Description
It was reported that a minibore bi-fuse ext, 2 iv cnntr, 2ckv experienced component separation during use.The following was reported by the initial reporter: "the device is not properly welded in all its connecting parts.Specifically, the set that connects to the cvc, in the part of the conjunction of the two branches of the octopus, also detaches with not necessarily violent stresses.Unfortunately this happened to a little patient of ours during an infusion.Since this is an event that cannot and must absolutely not happen as it exposes you to the risk of even substantial bleeding (which is what happened in part), of possible infection and leakage of antiblastics, i consider it appropriate to report it immediately.".
Additional Manufacturer Narrative
Investigation: a mz9279 sample was not available for investigation of this feedback; however the customer indicates that leakage was identified due to a joint separation at the "y" tubing-to-tubing connector.A review of the production records for lot 20016372 did not identify any in-process testing failures or quality deviations which may have resulted in a report for separation of the tubing at this component.Complaint could not be confirmed and the root cause could not be determined.

• Brand Name: MINIBORE BI-FUSE EXT, 2 IV CNNTR, 2CKV
• 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 22244 ; MX 22244
• MDR Report Key: 11023517
• Report Number: 9616066-2020-20574
• Device Sequence Number: 11886135
• Product Code: FPA
• UDI-Device Identifier: 50885403230620
• UDI-Public: 50885403230620
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MZ9279
• Device Catalogue Number: MZ9279
• Device Lot Number: 20016372
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention