MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-30 for MINI PERITONEAL LAVAGE KIT 9FR. MLNK9001 manufactured by Cardinal Health.
[16363684]
Product is breaking off when being used on patient. Further conversation with the customer revealed that the needle was in the patient and broke off, and a piece remained inside the patient. Unfortunately, further details could not be provided and the customer contact familiar with the incident did not respond to inquiries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00152 |
| MDR Report Key | 503532 |
| Date Received | 2003-12-30 |
| Date of Report | 2003-12-30 |
| Date Mfgr Received | 2003-12-01 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2004-01-02 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICA SHARPE-GREEG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | 400 EAST FOSTER ROAD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI PERITONEAL LAVAGE KIT 9FR. |
| Generic Name | MINI PERITONEAL LAVAGE K |
| Product Code | FKO |
| Date Received | 2003-12-30 |
| Model Number | MLNK9001 |
| Catalog Number | MLNK9001 |
| Lot Number | 3LD187 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 492319 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | MINI PERITONEAL LAVAGE KIT 9FR |
| Baseline Generic Name | MINI PERITONEAL LAVAGE |
| Baseline Model No | MLNK9001 |
| Baseline Catalog No | MLNK9001 |
| Baseline ID | NA |
| Baseline Device Family | PROCEDURE TRAY |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K813336 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-30 |