MAUDE Adverse Event Report: CARDINAL HEALTH CONNECT SFTY SCREW SPIKE NS; PUMP, INFUSION, ENTERAL

Model Number 77000FD

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports: there is a leak at the junction of the spike.

Manufacturer Narrative

The device history record (dhr) shows evidence that the product was released according to all established procedures and qa documentation.Three used samples and a box consisting of 22 unused samples were received at the manufacturing site for evaluation.A visual and functional inspection was performed on the returned samples and confirmed that the device leaked between the cross spike and detached cross spike from the line.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: CONNECT SFTY SCREW SPIKE NS
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12350696
• MDR Text Key: 268883347
• Report Number: 1282497-2021-10558
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521190818
• UDI-Public: 10884521190818
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 77000FD
• Device Catalogue Number: 77000FD
• Device Lot Number: 192030034
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1