MAUDE Adverse Event Report: COVIDIEN SILCON THORACIC CATH 32FR; CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Model Number	8888572560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that the drain used in thoracic surgery broke at its end when pulled from the plastic tube package for use in the patient.The drain end remained with the clamp that was used to pull it out.The health care provider used another drain and there was no consequence to the patient or delay in the procedure.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One used sample was received outside of the original package.A visual inspection was performed, and it appears that one of the edges of the silicone catheter was broken and the piece was cut by a sharp instrument causing it to bend and break.The same cut was detected below the original cut as well.The reported condition will be treated as not related to manufacturing since the tensile test passed according to specification.No corrective actions will apply.This complaint will be closed with no further action and will be used for tracking and trending purposes.
Event or Problem Description
The customer states the tubing broke while being inserted.The tube appeared intact when it was pulled from the plastic packaging and the health care provider proceeded to insert the tube into the patient when the part of the tube that was clamped, broke off and remained in the clamp.A new tube was used and there was no harm to the patient.

• Brand Name: SILCON THORACIC CATH 32FR
• Common Device Name: CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8781283
• Report Number: 1282497-2019-08554
• Device Sequence Number: 13962670
• Product Code: GBS
• UDI-Device Identifier: 10884521025479
• UDI-Public: 10884521025479
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2019

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: No Information
• Device Model Number: 8888572560
• Device Catalogue Number: 8888572560
• Device Lot Number: 183550275
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 06/18/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 07/11/2019; 11/18/2019
• Patient Sequence Number: 1