MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2014-11-21 for PROTOCO2L VC ADMINISTRATION SET FOLEY TIP 6470 manufactured by Ezem.
[5085286]
Narrative: on (b)(6) 2014 eidia co. Ltd, a bracco distributor in (b)(6) received info which was forwarded to bracco on (b)(6) 2014. A staff member of a hosp user facility reported; a malfunction with the protoco2l administration set for colon insufflation occurred. On (b)(6) 2014, (b)(6) male patient underwent a ct colonoscopy at a hosp where he was an inpatient. A protoco21 administration set for colon insufflation (list number 6470 lot number 50692036, expiration date 09/30/2014, single use device) was used for the procedure. The administration set rectal catheter balloon cuff volume was inflated with 25cc and insufflation was started then because co2 gas was leaking from the patient's anus the balloon cuff was inflated with an additional 10cc for a total of 35cc. Afterward the examination was started again, when that than 1. 5l but less than 2. 0l of co2 gas was administered, a noise like a rupture was heard. Insufflation of co2 gas was under 2. 0l and the pressure was 19 mmhg. Colon insufflation was suspended, the administration set catheter was pulled back from the patient. As a result the balloon cuff on the rectal catheter ruptured. There were no problems with the condition of the patient. The administration set was then exchanged for a new one to complete the ct colonography. The patient was returned to his room. There were no problems with the current condition fo the patient. A concomitant device, the protoco2l insufflation system, bracco catalogue number 6400 serial number (b)(4) , was used in conjunction with protoco21 administration set for colon insufflation worldwide case id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12709691]
Company comments: manufacturing narrative-bracco markets 2 device products used together to perform ct colonoscopy. One is the protoco2l colon insufflator system which administers carbon dioxide during ct colonoscopy for colon insufflation. The protoco2l is a concomitant device and no malfunction or problem was reported with its use. The reporter said the volume of co2 administered was between 1. 5 to 2. 0 liters and the pressure was 19 mmhg. The suspect device in this report is for the single use administration set used with the protoc2l insufflator. The set has a connector at one end which is inserted into the gas output of the protoco21 colon insufflator system. The other end of the administration set has a silicone rectal catheter with a balloon cuff for insertion into the patient's rectum. Co2 gas is delivered from the protoco2l insufflation system through the administration set to the patient's colon. The administration set also includes a syringe for inflating the balloon cuff. The package insert labeling includes an instruction to lubricate the catheter and retention cuff prior to insertions into the rectum and to inflate the balloon to 30cc using the provided syringe. The catheter cuff was inflated to 35cc. The balloon cuff ruptured during the procedure; however no harm to the patient as a result of the rupture was reported. A quality investigation is ongoing to determine the cause for this device failure. Company comment-the reported event describes a failure of the device during patient use. There was no adverse event or harm to this patient resulting from this failure. Additionally the labeling for the retention cuff states in capital lettering do not inflate the cuff with more than 30cc of air. Based on the above, even though the event did not cause an adverse event and the cuff was over inflated according to instructions, we decided to take a conservative approach and to report this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2014-00011 |
| MDR Report Key | 4305742 |
| Report Source | 01,05,06,08 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-10-30 |
| Date of Event | 2014-10-22 |
| Date Mfgr Received | 2014-10-30 |
| Date Added to Maude | 2014-12-17 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 259 PROSPECT PLAINS RD BLD.H. |
| Manufacturer City | MONROW TWP NJ 08831 |
| Manufacturer Country | US |
| Manufacturer Postal | 08831 |
| Manufacturer Phone | 8002575181 |
| Manufacturer G1 | EZEM |
| Manufacturer Street | 532 BROADHOLLOW RD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTOCO2L VC ADMINISTRATION SET FOLEY TIP |
| Generic Name | PROTOCO2L VC ADMINISTRATION SET FOLEY TIP |
| Product Code | FCX |
| Date Received | 2014-11-21 |
| Model Number | NI |
| Catalog Number | 6470 |
| Lot Number | 05692036 |
| ID Number | NA |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EZEM |
| Manufacturer Address | 532 BROADHOLLOW RD, STE 126 MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |