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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; DRAIN BAG
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C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; DRAIN BAG Back to Search Results
Device Problems Restricted Flow rate (1248); Improper Flow or Infusion (2954)
Patient Problems Muscle Spasm(s) (1966); Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported that the indwelling catheter was not draining well.It became even more of an issue after iv lasix was given - the patient began having bladder spasms and pressure.The rn assessed the catheter bag and noticed very little urine had been draining so the rn pulled the spine apart from the bag to help with the vapor lock issue and urine began draining.The rn had to frequently check the catheter the remainder of the shift to ensure it was draining properly.No medical intervention was reported.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿bag will not expand/vinyl stuck together¿ with a potential root cause of ¿static or positive air pressure¿.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product code is unknown, the drain bag product labeling is 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 the indwelling catheter was not draining well.It became even more of an issue after iv lasix was given - the patient began having bladder spasms and pressure.The rn assessed the catheter bag and noticed very little urine had been draining so the rn pulled the spine apart from the bag to help with the vapor lock issue and urine began draining.The rn had to frequently check the catheter the remainder of the shift to ensure it was draining properly.No medical intervention was reported.
 
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Brand Name
URINE COLLECTION
Type of Device
DRAIN BAG
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9745447
MDR Text Key184094478
Report Number1018233-2020-01266
Device Sequence Number1
Product Code EZL
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 03/29/2020
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 02/06/2020
Initial Date FDA Received02/24/2020
Supplement Dates Manufacturer Received03/17/2020
Supplement Dates FDA Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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