MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 8FR

Model Number 8888560805

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

Customer reports: an 8fr chest tube needle stuck into the chest tube.We were unable to remove or use it to insert the tube.The chest tube was being placed in an emergency and as such insertion was delayed as another tube had to be found and inserted.The impact to the patient was prolonged care.

Manufacturer Narrative

The device history record file was reviewed, and no discrepancy was found that could lead to the reported condition.One sample was received for evaluation.After performing an inspection of the sample, the condition reported as ¿difficult to remove rod from catheter¿ is confirmed.Because the catheter tip is a molded insert, it is possible that during tip forming, the catheter hole has exceeded the heating exposure causing the catheter to dry up with the assembled rod, which affected the rod tip size, causing the device to become difficult to remove.To avoid the thermal contractions of the catheter when the material is malleable, an additional process step requires the insertion and removal of the rod from catheter for all assembled units of the lot after the forming of the catheter tip was included as part of the standard work instruction to ensure the correct insert and removal from the rod.Based on a gemba walkthrough, the manufacturing process was reviewed and verified that all process and controls were followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.In addition, quality control inspections are performed on the product for material release.Production personnel perform a 100% visual inspection during the packaging process to detect and discard any identified non-conforming product.

• 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: 13997699
• MDR Text Key: 291380364
• Report Number: 9612030-2022-03202
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 10884521050310
• UDI-Public: 10884521050310
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888560805
• Device Catalogue Number: 8888560805
• Device Lot Number: 1929617064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1