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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE TRAY; KDQ BOTTLE, COLLECTION, VACUUM
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COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE TRAY; KDQ BOTTLE, COLLECTION, VACUUM Back to Search Results
Model Number N/A
Device Problem Split (2537)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2014
Event Type  malfunction  
Event Description
Upon removal of wire from the patient, the wire was noted to be split approximately one third down from the distal end, coating also appeared stripped.Another wire was used to complete the procedure successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.
 
Manufacturer Narrative
(b)(4).The event is currently under investigation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Upon removal of wire from the patient, the wire was noted to be split approximately one third down from the distal end, coating also appeared stripped.Another wire was used to complete the procedure successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of complaint history, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The product was returned in an opened and used condition.A visual inspection noted that the wire split approximately one third down from the distal end, the coating also appeared stripped.The wire also appeared bent distal from where the catheter split.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an ifu which states warnings, precautions and instructions for use.We are unable to determine with certainty the root cause for the experienced difficulty.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), no further risk reduction is required.
 
Event Description
Upon removal of wire from the patient, the wire was noted to be split approximately one third down from the distal end, coating also appeared stripped.Another wire was used to complete the procedure successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand Name
FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE TRAY
Type of Device
KDQ BOTTLE, COLLECTION, VACUUM
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key4417431
MDR Text Key5376092
Report Number1820334-2015-00024
Device Sequence Number1
Product Code KDQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2015
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-PPDY-700-022394-IMH
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/09/2014
Device Age NA
Event Location Hospital
Date Manufacturer Received12/18/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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