MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV MICROBORE QUAD-FUSE EXTENSION SET, 4 IV; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9275
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
Medical 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 while attaching the microbore quad-fuse extension set, 4 iv to "broviac", a crack was noticed in the hub.The following information was provided by the initial reporter: "noticed a crack in the hub when attaching line to broviac.Disconnected and replaced".
Event or Problem Description
It was reported that while attaching the microbore quad-fuse extension set, 4 iv to "broviac", a crack was noticed in the hub.The following information was provided by the initial reporter: "noticed a crack in the hub when attaching line to broviac.Disconnected and replaced".
Additional Manufacturer Narrative
It was reported that there was a crack in the hub.Received one used extension set model mz9275 lot unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.No evidence of damages (cracks) or anomalies were observed at the components or throughout the set during initial visual inspection.Functional testing was performed by attaching one lab syringe filled with blue dye water to each of the set¿s nac zeros¿ injections ports.One lab stopcock in closed position was attached the set¿s male luer.The syringe plunger was gently depressed and no leaks or any issues were observed.The stopcock was then opened and a second attempt of a syringe push was performed at each of the nac zeros.No leaks, cracks, or any issues were observed.The set was pressure tested at each injection port while submerged underwater (per dir # (b)(4) ¿ iv disposable leak test method).Air pressure was incrementally increased from 5 psi to 30 psi.No leaks or any anomalies were observed the set or at the components.Model mz9275¿s female/male ports were measured and found to be within iso standards with the male go/nogo gauges.Equipment used (measurement and testing performed on (b)(6)2020) - air pressure regulator with pressure gauge, eq00138, calibration due date: 02oct2020 - male go/no go gauge, eq08244, calibration due date: 12sep2020.- female go/no go gauge, eq08248, calibration due date: 12sep2020.The customer¿s report that there was a crack in the hub was not confirmed.The root cause of the customer¿s experience was not identified because no damages or anomalies were observed or replicated during functional and pressure testing.A device history record could not be performed due to no lot number was provided by the customer.H3 other text : see h10.

• Brand Name: MICROBORE QUAD-FUSE EXTENSION SET, 4 IV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10237679
• Report Number: 9616066-2020-02094
• Device Sequence Number: 11370881
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: 10885403240768
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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 Model Number: MZ9275
• Device Catalogue Number: MZ9275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 20200611; 20200611
• Outcome Attributed to Adverse Event: Other