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 Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2020
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 minibore bi-fuse ext, 2 iv cnntr, 2ckv was damaged.The following information was provided by the initial reporter: breakage of the end of a 2-way connector in the light of the kt piccline therefore now unusable.
Event or Problem Description
It was reported that minibore bi-fuse ext, 2 iv cnntr, 2ckv was damaged.The following information was provided by the initial reporter: breakage of the end of a 2-way connector in the light of the kt piccline therefore now unusable.
Additional Manufacturer Narrative
H6: investigation summary a sample was not available for investigation of this feedback; however the customer indicates that the male luer component was damaged whilst attempting to disconnect it from the picc.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.A review of the customer feedback database indicates that this is an isolated occurrence with no other similar report against the mz9279 set in the past 12 months.

• 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: 10710184
• Report Number: 9616066-2020-20144
• Device Sequence Number: 3259614
• Product Code: FPA
• UDI-Device Identifier: 50885403230620
• UDI-Public: 50885403230620
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/11/2020

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: Other
• Device Model Number: MZ9279
• Device Catalogue Number: MZ9279
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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: Other