MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-07 for CATHETER PLUG W/ PROTECTOR CAP 1600 manufactured by Covidien.
[19993446]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a urinary catheter plug. The customer states the catheter plug leaked, there was a hole at the tip. There was no medical intervention required. This was used on a patient that was on chemotherapy. This was caught in the recovery room and changed. The customer was concerned that the chemotherapy drug could have leaked out of the bladder and exposed the transport staff and nursing staff to the drug without protective attire and precautions if they didn't catch it in the recovery room.
Patient Sequence No: 1, Text Type: D, B5
[20284629]
Submit date: 03/07/2015. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[32224158]
The device history record file was reviewed indicating that product was released meeting all quality standard requirements. There were no non-conforming issues reported during the manufacture of this product for a similar condition as reported in this complaint. A sample was received for evaluation. After a visual and functional inspection was performed, the issue reported was confirmed. The connector was leaking. The most possible root causes can be due to a variation in the temperature the mold, variation of the cooling in the mold or wear in the gate mold. The process is running according to product specifications meeting quality acceptance criteria. The production personnel were notified about the reported issue. A quality alert was issued to make the production personnel aware of the reported issue. As a corrective action, the mold will be repaired and the insert gates will be modified to eliminate the high injection point generated during the current molding process. Once the insert gates are modified, the high injection point will be eliminated. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2015-00021 |
| MDR Report Key | 4579527 |
| Report Source | 06,07 |
| Date Received | 2015-03-07 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-02-17 |
| Date Mfgr Received | 2015-07-30 |
| Date Added to Maude | 2015-03-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER PLUG W/ PROTECTOR CAP |
| Generic Name | CATHETER PLUG |
| Product Code | FCN |
| Date Received | 2015-03-07 |
| Model Number | 1600 |
| Catalog Number | 1600 |
| Lot Number | 420382764 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-07 |