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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION
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COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The event is currently under investigation.
 
Event 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.
 
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 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.
 
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.
 
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Brand Name
FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
Type of Device
GBX CATHETER, IRRIGATION
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key5811828
MDR Text Key50088736
Report Number1820334-2016-00651
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00827002557239
UDI-Public(01)00827002557239(17)190202(10)6704453
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberC-PPD-850-IMH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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