MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-02 for HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL 82-3072 manufactured by Codman & Shurtleff, Inc. Medos S.a..
[9351235]
It was noted that this complaint could not be confirmed. The device was visually and functionally tested and was found to work in accordance with the manufacturing specifications. The problem reported by the customer could not be duplicated in the laboratory setting. A review of the device history records confirmed that this device conformed to the required specifications prior to distributions. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
[18841949]
Customer explained in a phone conversation that the ventricular catheter was hooked up to a medtronic valve and the reservoir would depress and not refill. It was noted that when hooked up to the monometer there was no flow through the ventricular catheter. When the catheter was replaced and hooked back p to the monometer the device worked.
Patient Sequence No: 1, Text Type: D, B5
[19038250]
Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00291 |
| MDR Report Key | 2194601 |
| Report Source | 05,06 |
| Date Received | 2011-08-02 |
| Date of Event | 2011-05-05 |
| Date Mfgr Received | 2011-07-05 |
| Device Manufacturer Date | 2011-01-19 |
| Date Added to Maude | 2011-08-19 |
| 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 | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. MEDOS S.A. |
| Manufacturer Street | RUE GIRARDET 29 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS |
| Product Code | HCA |
| Date Received | 2011-08-02 |
| Returned To Mfg | 2011-07-18 |
| Model Number | NA |
| Catalog Number | 82-3072 |
| Lot Number | CMBBHK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. MEDOS S.A. |
| Manufacturer Address | RUE GIRARDET 29 LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-02 |