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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE
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C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE Back to Search Results
Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that 30 minutes after the hemovac drain was placed in the patient's lumbar spine, air was noted in the tubing.The patient was then turned and it was noted that the was disconnected at the y site just above the top of the dressing.The complainant reported that the drain was then replaced from the y site to the drain chamber.
 
Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be ¿connection is not sufficient¿.A potential root cause for this failure could be "bonding strength is insufficient".The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this wound drainage product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product family is unknown, the wound drainage product ifus are found to be adequate based on past reviews.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
Event Description
It was reported that 30 minutes after the hemovac drain was placed in the patient's lumbar spine, air was noted in the tubing.The patient was then turned and it was noted that the was disconnected at the y site just above the top of the dressing.The complainant reported that the drain was then replaced from the y site to the drain chamber.
 
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Brand Name
WOUND DRAINAGE
Type of Device
WOUND DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8787432
MDR Text Key151007563
Report Number1018233-2019-03883
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/29/2019
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/24/2019
Initial Date FDA Received07/13/2019
Supplement Dates Manufacturer Received07/16/2019
Supplement Dates FDA Received07/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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