MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-16 for AIR TIP ENEMA AIR TIP Q09 manufactured by .
[21677038]
Customer reports that during a barium enema procedure, a piece of the equipment, a small air valve, was found to be in the patient's large bowel. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
[21831396]
Details of investigation: returned enema tip (q9) was already cut along axis of where non-return valve is positioned. Sample had a non-return valve in situ. Teleconference between customer and manufacturing quality department established that the returned sample was not the actual device used on the patient. This was disposed at the time of the procedure and the incident not being detected until examination of the x-ray. Conclusion: a probable explanation is that a second non-return valve was pushed into the side shaft. This dislodged the first non-return valve pushing it forward to the position where its leading edge was just entering the main shaft. Subsequently, on the delivery of the viscous barium sulphate this dislodged the first valve, permitting it to enter the patient's bowel. This incident is the first we have received of this nature. Corrective action: in this case, we have highlighted the complaint to supervisors and operators in assembly departments to re-enforce their product training and understanding of failure mode. No further checks were deemed appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1827430-2008-00001 |
| MDR Report Key | 1051339 |
| Report Source | 05,06 |
| Date Received | 2008-05-16 |
| Date of Report | 2003-05-16 |
| Date of Event | 2003-04-23 |
| Date Mfgr Received | 2003-05-16 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2008-09-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR TIP |
| Generic Name | BARIUM ENEMA TIP |
| Product Code | FCD |
| Date Received | 2008-05-16 |
| Model Number | ENEMA AIR TIP |
| Catalog Number | Q09 |
| Lot Number | 021015085 |
| ID Number | NA |
| Device Expiration Date | 2005-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1045741 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-16 |