MAUDE Adverse Event Report: COOK INC PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient was undergoing a pericardiocentesis using a pericardiocentesis catheter set.When he applied negative pressure using a syringe after placing the catheter, some air came in to the system.Blood leakage was observed between the catheter and connecter.The physician removed and replaced the catheter to complete the procedure.There are no reported adverse patient consequences.
Additional Manufacturer Narrative
Additional information: device evaluated by mfr.Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One pericardiocentesis catheter set was returned for evaluation.A functional test was performed and the device was found to leak in the tubing at the hub.The hub was removed from the catheter.A visual examination noted the flare has a hole at the base.During the manufacturing process, all catheters are required to be confirmed free of any leaks and/or communication between lumens and in manifold.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, the root cause of this event was determined to be related to the manufacturing process.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: PERICARDIOCENTESIS CATHETER SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6641400
• Report Number: 1820334-2017-01402
• Device Sequence Number: 981455
• Product Code: GBX
• UDI-Device Identifier: 00827002106437
• UDI-Public: (01)00827002106437(17)191025(10)7336607
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: N/A
• Device Catalogue Number: C-PCS-700-TORONTO-042997
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1