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.
[2926334]
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
[10397439]
(b)(4). 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)(6) 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. Amy further stated that pt's condition is stable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2012-00054 |
| MDR Report Key | 2833126 |
| Report Source | 00 |
| Date Received | 2012-11-07 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-07-12 |
| Report Date | 2012-10-25 |
| Date Reported to FDA | 2012-09-01 |
| Date Reported to Mfgr | 2012-10-25 |
| Date Mfgr Received | 2012-10-25 |
| Date Added to Maude | 2012-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARLA CALDERON |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618622 |
| Manufacturer G1 | COVIDIEN LP |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENEMA BAG |
| Generic Name | ENEMA BAG |
| Product Code | FCE |
| Date Received | 2012-11-07 |
| Model Number | 145540 |
| Catalog Number | 145540 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-07 |