MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. MAXGUARD MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP9213-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of maxguard multi-fuse extension sets with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: i was in ct with a patient who needed contrast and had to be monitored.The ct alarmed after a few minutes with an occlusion.When we went to investigate and the j-loop had split with blood and contrast leaking everywhere making it very difficult to fix.I don't know if it was due to the contrast or if it was just a fluke but this is the first time i've seen this happen since using them.After speaking with the team leader he said it was the actual tubing was split.
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: 07/06/2020.Investigation conclusion: it was reported the tubing was split (damaged) while using a contrast machine.Received one used extension set model mp9213-c lot unknown.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection observed a section of the tubing (p/n tnd0018-5.25) was ruptured or ¿split¿ and deformed near the male luer.Further examination of the affected tubing area was weakened or softened from the damage.Residual red liquid presumed to be contrast was observed within the set.No other anomalies were observed during initial visual inspection.Functional testing could not be performed due to the split tubing.Equipment used (inspection performed on (b)(6)2020) optical ram-cnc, eq08204, calibration due date: (b)(6)2021.A device history record for model mp9213-c could not be performed due to no lot number being provided by the customer.The customer¿s report the tubing was split (damaged) while using a contrast machine was confirmed as received.The root cause of the ruptured tubing was due to the excessive pressure that exceeded that maximum pressure that the model mp9213-c tubing can handle.Model mp9213-c is not intended and rated for high pressure functionality.H3 other text : see h10.
Event or Problem Description
It was reported that an unspecified number of maxguard multi-fuse extension sets with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: i was in ct with a patient who needed contrast and had to be monitored.The ct alarmed after a few minutes with an occlusion.When we went to investigate and the j-loop had split with blood and contrast leaking everywhere making it very difficult to fix.I don't know if it was due to the contrast or if it was just a fluke but this is the first time i've seen this happen since using them.After speaking with the team leader he said it was the actual tubing was split.

• Brand Name: MAXGUARD MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10305828
• Report Number: 9616066-2020-02287
• Device Sequence Number: 860504
• Product Code: FPA
• UDI-Device Identifier: 10885403236976
• UDI-Public: 10885403236976
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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,Followup
• Report Date (Section B): 07/01/2020

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: MP9213-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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