MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 8FR

Model Number 8888560805

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported that they were about to use a catheter on a baby that was coding in the nicu and they weren¿t able to get the catheter to deploy from the tip and it seems like they are adhered together.The physician discovered the issue before using it on the baby, so there was no harm to the patient involved.

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.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One sample was received for the evaluation.Upon inspection, the reported condition is confirmed.The root cause of the reported issue is since the catheter tip is a molded insert, it is possible that during tip forming, the catheter hole has exceeded the heating exposure; causing that when catheter it dried with the assembled rod, the catheter material was contracted by the tip hole to the rod tip size, causing difficult to remove it.As an action plan, an additional process step was included to ensure the correct insert and removal from rod, this will avoid the thermal contraction of catheter when the material is malleable.

• Brand Name: TROCAR CATH 8FR
• Type of Device: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12814082
• MDR Text Key: 281863714
• Report Number: 9612030-2021-03090
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 10884521050310
• UDI-Public: 10884521050310
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888560805
• Device Catalogue Number: 8888560805
• Device Lot Number: 1915543664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2021
• 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