MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR,.F; SET, ADMINISTRATION, INFUSION

Model Number MZ9226

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Difficult or Delayed Separation (4044)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that microbore extension set, iv connector,.F cap broke.The following information was provided by the initial reporter: material no.: mz1000-07 batch no.: unknown.It was reported that, the maxzero cap broke.We had a problem with one of the maxzero caps.The mz9226 was delivering tpn via syringe and the nurse noticed the blue silicone poppet did not rebound.After you looked at the mz further, you noticed that it potentially has a piece of the male luer broken off inside the mz cap.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: (b)(6) 2020.Investigation conclusion it was reported that a piece of the male luer broken off inside the maxzero cap.Received from the customer is the male luer tip of extension set model mz9226 lot unknown.The maxzero were visually inspected for cracks, misassemblies or damages to the components.Visual inspection found that a male luer tip (p/n (b)(6) of extension set model mz9226 was broken off into the female luer port of the maxzero.Closer inspection under a lab microscope observed stress marks on the break site of the male luer tip.No tool marks were observed on the maxzero.An attempt to remove the male luer tip from the maxzero¿s female luer was unsuccessful.Equipment used for testing on (b)(6) 2020: ¿ optical ram-cnc eq 08204 (b)(6) 2021 device history record for model mz9226 could not be performed due to no lot number being provided by customer.The customer¿s report that a piece of the male luer broken off inside the mz cap was confirmed.The root cause of the break is due to excessive outside force on the male luer as indicated by the visible stress marks observed on the broken male luer tip.The root cause of the outside force could not be determined.

Event Description

It was reported that microbore extension set, iv connector,.F cap broke.The following information was provided by the initial reporter: material no.: mz1000-07 batch no.: unknown it was reported that, the maxzero cap broke.We had a problem with one of the maxzero caps.The mz9226 was delivering tpn via syringe and the nurse noticed the blue silicone poppet did not rebound.After you looked at the mz further, you noticed that it potentially has a piece of the male luer broken off inside the mz cap.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR,.F
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10274104
• MDR Text Key: 225929840
• Report Number: 9616066-2020-02168
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: 10885403240621
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ9226
• Device Catalogue Number: MZ9226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200621; 20200621
• Patient Outcome(s): Other