MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ1000

Device Problem Failure to Disconnect (2541)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

The model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mz1000-07.The 510k number provided for the domestic similar product.The product has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.

Event Description

The reported feedback suggests that there are connection issues in which the connector adhered very strongly to the catheter and was difficult to disconnect, requiring use of clamps as a tool to disconnect.The user had an occupational joint disease, which limits her ability to perform force procedures.Prior to the event the user's arm was not inflamed, but afterward due to the force used it became swollen, very painful, and inflamed.The user went to occupational medicine and was put on disability.

Event Description

The reported feedback suggests that there are connection issues in which the connector adhered very strongly to the catheter and was difficult to disconnect, requiring use of clamps as a tool to disconnect.The user had an occupational joint disease, which limits her ability to perform force procedures.Prior to the event the user's arm was not inflamed, but afterward due to the force used it became swollen, very painful, and inflamed.The user went to occupational medicine and was put on disability.

Manufacturer Narrative

The customer¿s report that the maxzero was difficult to disconnect was confirmed.Visual inspection of the set showed damage to the female luer.There were no other anomalies observed.During functional testing a large amount of force was required to separate the connection; additionally stress marks were visible at the male luer of the maxzero component.The concomitant non-bd extension set was reconnected to the maxzero with a half turn; no issues were identified during subsequent disconnection.The root cause of the customer¿s report was not identified.Possible factors include over-torque of the component during connection with the male luer, use of a male luer that is not compliant to iso standards, or prolonged use of substances that are aggressive to plastics.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7981075
• MDR Text Key: 124291015
• Report Number: 9616066-2018-01996
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000
• Device Catalogue Number: MZ1000
• Device Lot Number: 17076668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other