MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-16 for FLEXIBLE TIP WITH SLIMLINE RETENTION 119042 manufactured by Covidien.
[18332736]
Customer reports enema tip separated from the clear plastic adapter that attaches to the bag and entered the patient's body during a procedure. Patient was a male. Complainant inspected other tips in the box and found at least one other where the tip were not securely fastened to the adapter. It slides out as if the adapter was too small or there was no glue on it (not snug). Two cases will be returned for investigation. The used tips were discarded.
Patient Sequence No: 1, Text Type: D, B5
[18346527]
Root cause: this defect is an operational error due that the glue is applied to the tip and adapter manually. Conclusions: device history record was reviewed finding no defects detected in the inspection of this lot. Twenty one samples were received from lot number 3202055 of model number 119042. All samples were evaluated under procedure for tensile strength and in fact, in one of the samples, the plastic adapter gets loose. Therefore this complaint was confirmed. Corrective actions: a notification report is being issued to inform all personnel within the enema tips assembly process about this problem. Our production process is being checked putting special attention on this issue. With the reference reported, notification was provided to appropriate manufacturing and quality assurance personnel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-2008-00010 |
| MDR Report Key | 1051373 |
| Report Source | 05 |
| Date Received | 2008-05-16 |
| Date of Report | 2003-12-04 |
| Date of Event | 2003-12-04 |
| Date Mfgr Received | 2003-12-04 |
| Device Manufacturer Date | 2006-07-01 |
| 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 | 211 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 | FLEXIBLE TIP WITH SLIMLINE RETENTION |
| Generic Name | ENEMA TIP |
| Product Code | FCE |
| Date Received | 2008-05-16 |
| Model Number | FLEXIBLE TIP |
| Catalog Number | 119042 |
| Lot Number | 3202055 |
| ID Number | NA |
| Device Expiration Date | 2006-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1045718 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-16 |