MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 8FR

Model Number	8888560805
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2022-03202
• Device Sequence Number: 14673750
• Product Code: DRC
• UDI-Device Identifier: 10884521050310
• UDI-Public: 10884521050310
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown