MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2014-08-21 for NON LATEX MILLER AIR TIP 650012 manufactured by Ezem.
[4857273]
Narrative: case was received from a hospital fluoroscopy and cardiology lead radiographer at (b)(6). On (b)(6) 2014 and forwarded to (b)(6). On (b)(6) 2014. On (b)(6) 2014, additional information was received from the primary reporter directly at (b)(6). A health professional reports: on (b)(6) 2014, there were 3 incidents of balloon failing to deflate (non latex miller air tip, system model no. 650012, lot/serial no. (b)(4)) when removing the catheter. Catheters were not kept but 1. 5 bags left of the same batch which dept are now reluctant to use. No patients had any adverse consequences as a result of the balloon not deflating. The return of one unused sample of the same batch for investigation has been requested. Outcome: recovered. Further information has been requested. Worldwide case id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12434164]
Company comments: a healthcare professional reported that in 3 barium enema tests, the balloon failed to deflate while removing the catheter. Generally, during this type of examination, a lubricated enema tip is inserted into patient's rectum. The tip has a balloon that could be inflated just enough to keep barium from leaking out (of note, not necessarily the balloon should be completely inflated). As reported in labeling, the deflation of the balloon should be started after completion of fluoroscopy phase of the exam or after the colon is completely filled with barium and should be completed before removing the enema tip. This approach guarantees good images during the examination and avoids lesions in extracting a fully inflated balloon. Based on the above and considering that no clinical consequences were reported in the 3 patients, the manufacturer argues that in these cases the balloon was at least partially deflated before removing it. In fact, the removal of a fully inflated balloon would have been quite impossible and would have led to a difficult extraction maneuvers with traumatic lesions of the rectum or anus. In any case, since the information on manufacturer's hands is very scanty, it was decided to have a conservative approach and to report these cases.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2014-00004 |
| MDR Report Key | 4077252 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-07-16 |
| Date Mfgr Received | 2014-07-17 |
| Date Added to Maude | 2014-09-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 259 PROSPECT PLAINS ROAD, BLDG H |
| Manufacturer City | MONROE TWP NJ 08831 |
| Manufacturer Country | US |
| Manufacturer Postal | 08831 |
| Manufacturer Phone | 8002575181 |
| Manufacturer G1 | EZEM |
| Manufacturer Street | 532 BROADHOLLOW ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NON LATEX MILLER AIR TIP |
| Generic Name | CATHETER RETENTION BARIUM ENEMA WITH BAG |
| Product Code | FGD |
| Date Received | 2014-08-21 |
| Model Number | 650012 |
| Catalog Number | NI |
| Lot Number | 50724360 |
| ID Number | NA |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EZEM |
| Manufacturer Address | 532 BROADHOLLOW ROAD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-21 |