MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION

Model Number	N/A
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a drainage procedure on the female patient, it was reported that the user first punctured with the needle and entered wire guide through the needle.They then dilated and entered the drain.However, when they wanted to retrieve the wire it was stuck.The user had to pull and heard a "knick" and the wire loosened.Information was provided that the wire was tattered and the drain came loose from the connection.The patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
During a drainage procedure on the female patient, it was reported that the user first punctured with the needle and entered wire guide through the needle.They then dilated and entered the drain.However, when they wanted to retrieve the wire it was stuck.The user had to pull and heard a "knick" and the wire loosened.Information was provided that the wire was tattered and the drain came loose from the connection.The patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation a review of the complaint history, device history record, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.Customer provided a photo of the actual device for evaluation.The photo shows a wire guide that is stretched and has unraveled and has the wire mandril sticking out of it.The actual device was received and visually examined.The returned wire guide is partially unraveled.There appears to be two breaks in the in the wire with bare wire protruding at both sites.The coating of the wire guide appears intact.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5811828
• Report Number: 1820334-2016-00651
• Device Sequence Number: 13681059
• Product Code: GBX
• UDI-Device Identifier: 00827002557239
• UDI-Public: (01)00827002557239(17)190202(10)6704453
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2017

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-PPD-850-IMH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/21/2016
• Supplement Report FDA Received Date: 10/20/2016; 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1