MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. EXT SET TRI-FUSE 7 W SLIDE CLAMP; EXTENSION SET

Catalog Number	MZ9327
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.Device history record review could not be performed on model mz9327 because a lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no product will be returned per customer.No investigation was performed.Root cause description: the root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that the ext set tri-fuse 7 w slide clamp experienced damage/deformation.The following information was provided by the initial reporter: we had another incident today that i was able to document with pictures.The same baby who had to have a new central line placed last week, was found to have a cracked and leaking mz1000-07 again today on her new picc.This device was connected to the hub of the picc, which was connected to the tri-port.When we broke it all down and replaced, the crack was visible and hopefully you can see how that contributed to the leaking and loss of tpn and lipids.Customer response: are you able to provide a description of the issue detected with this product? -i understand this extension set was attached to the needless connector and was also leaking.The extension set did not appear to be leaking so that has not been saved.

• Brand Name: EXT SET TRI-FUSE 7 W SLIDE CLAMP
• Common Device Name: EXTENSION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10222281
• Report Number: 9616066-2020-02082
• Device Sequence Number: 2485255
• Product Code: FMG
• UDI-Device Identifier: 10885403427268
• UDI-Public: 10885403427268
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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 Catalogue Number: MZ9327
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2020
• 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