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	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(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: the connection of the 2-way connector connected to the picc line broke when unscrewing it for its weekly change.Impossible to remove under sterile care (sterile care).Use of non-sterile clamps.
Additional Manufacturer Narrative
H6: investigation summary a mz9279 sample was not available for investigation of complaint (b)(4); however the customer indicates that the male luer was damaged when attempting to disconnect it from the picc line.Further information regarding the feedback was not available to assist the investigation.The connecting product in use at the time of the customer's experience was not returned to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 19105787 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.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 a rare occurrence with this customer being the only customer to provide this type of feedback against the mz9279 product in the past 12 months.
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: the connection of the 2-way connector connected to the picc line broke when unscrewing it for its weekly change.Impossible to remove under sterile care (sterile care).Use of non-sterile clamps.

• 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: 10954093
• Report Number: 9616066-2020-20517
• Device Sequence Number: 3019302
• 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): 12/22/2020

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: Other
• Device Expiration Date: 10/09/2022
• Device Model Number: MZ9279
• Device Catalogue Number: MZ9279
• Device Lot Number: 19105787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR