MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 8FR

Model Number	8888560805
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• 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: 12814082
• Report Number: 9612030-2021-03090
• Device Sequence Number: 20054646
• Product Code: DRC
• UDI-Device Identifier: 10884521050310
• UDI-Public: 10884521050310
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 11/01/2021; 11/01/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/16/2021; 01/05/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown