ENEMA BAG 145540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-11-07 for ENEMA BAG 145540 manufactured by Covidien.

Event Text Entries

[3076878] It was reported to covidien on (b)(6) 2012 that a customer had an issue with an enema bag. The customer reports; the pt reported rectal fullness and blood on toilet paper. An anema had been administered earlier in the day. Upon examination a blue, approx 5-inch plastic cap from the enema bag tubing, was found in the pt's rectum. The rn did not realize the cap should be removed. There is no labeling on the cap not to insert into pt. There is also nothing in the product literature to ensure the cap is removed and disposed of prior to insertion into pt.
Patient Sequence No: 1, Text Type: D, B5


[10271037] Submit date: (b)(4) 2012. An investigation is currently underway, upon completion the results will be forwarded. Covidien product monitoring contacted the customer on (b)(4) 2012 to request add'l info. On (b)(4) 2012, (b)(4) from the risk management office communicated that per hospital's policy, info regarding pt's medical procedures is considered confidential and no add'l info could be provided. (b)(4) further stated that pt's condition is stable.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612030-2012-00055
MDR Report Key2833127
Report Source00
Date Received2012-11-07
Date of Report2012-10-25
Date of Event2012-07-12
Report Date2012-10-25
Date Reported to FDA2012-09-01
Date Reported to Mfgr2012-10-25
Date Mfgr Received2012-10-25
Date Added to Maude2012-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARLA CALDERON
Manufacturer Street15 HAMPSHIRE ST
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5082618622
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
Manufacturer CityTIJUANA 92173
Manufacturer CountryMX
Manufacturer Postal Code92173
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENEMA BAG
Generic NameENEMA BAG
Product CodeFCE
Date Received2012-11-07
Model Number145540
Catalog Number145540
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 TIJUANA 92173 MX 92173


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-11-07

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