MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-03-11 for PROTOCOL21 ADMINISTRATION SET 6470 manufactured by Bracco Diagnostic Inc.
[15835334]
Narrative: case was received from a radiographer via (b)(4) on (b)(6) 2015 and forwarded to quintiles ls (operating on behalf of (b)(4)) on the same day. A health professional reports: a (b)(6) male patient with unknown medical history and concomitant medications underwent an unknown diagnostic procedure with protocol21 admin set (catalogue no 6470, lot number 50829828) on (b)(4) 2015. A radiologist carried out the examination of patient and found that he was unable to deflate the balloon catheter at the time of examination. The only wa y was to cut the tubing and this then deflated the balloon. The patient was unaware of situation and was able to complete the examination but the radiologist was concerned of what he happened at the time. The reporter stated that this was the first time this had been seen with these catheters and has not been experienced again since. As cause of the event it was reported, that it appeared to be a stuck valve in the catheter. The device unit was still in use, the valve cut from tubing set was sent for further investigation. Outcome: recovered/resolved. Investigation results are expected. Worldwide case id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16061772]
Company comments: a (b)(6) male patient with unknown medical history and concomitant medications underwent an unknown diagnostic procedure with protocol21 admin set (catalogue no 6470, lot number 50829828). The radiologist that carried out patient's examination, found that he was unable to deflate the balloon catheter during the examination. The only way deflate the balloon was to cut the tubing. The examination was completed and no harm to the patient occurred. It appears that this event could be caused by a stuck valve in the catheter. The investigation results of the returned sample is pending and there is no evidence of previous similar malfunctions with the medical device. Nonetheless, considering that it is important to obtain the deflation of the balloon before its extraction from the patient's rectum to avoid complex maneuvers that can determine traumatic lesion of the rectum or anus, (b)(4) has decided to have a conservative approach and to report this case. A reassessment of the event will be done once the investigation results will be available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2015-00001 |
| MDR Report Key | 4602754 |
| Report Source | 00 |
| Date Received | 2015-03-11 |
| Date of Report | 2015-02-03 |
| Date of Event | 2015-01-29 |
| Date Added to Maude | 2015-05-22 |
| 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 | 750 SUMMA AVE. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer G1 | E-Z-EM, INC. |
| Manufacturer Street | 750 SUMMA AVE. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11590 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTOCOL21 ADMINISTRATION SET |
| Generic Name | ADMINISTRATION SET OF NON-INJECTEUR DEVICE |
| Product Code | FCX |
| Date Received | 2015-03-11 |
| Returned To Mfg | 2015-02-02 |
| Model Number | NI |
| Catalog Number | 6470 |
| Lot Number | 50829828 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO DIAGNOSTIC INC |
| Manufacturer Address | BRACCO HOUSE, MERCURY PARK BUCKS HP100HH UK HP10 0HH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-11 |