MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-12 for CODMAN BACTISEAL VENTRICULAR CATHETER manufactured by Codman & Shurtleff, Inc..
[4370031]
On (b)(6) 2014, pt went to md for five month follow-up. Pt had mri this day. Mom and grandmother voiced concern over baby having extreme irritability, not sleeping, waking up screaming and holding ears and back of head when crying. A shunt tap was performed and there was no spontaneous flow. There was minimal flow with negative suctioning. Mom reports baby fussy and cries at nights during sleep. Baby has recently had increase in fussiness and irritability, some swelling over the forehead. Recommendations were a proximal shunt revision. Baby brought to the hospital on (b)(6) 2014 and surgery performed. Old proximal catheter when disconnected from the shunt valve there was very slow cerebrospinal fluid leaking so the old proximal catheter was removed. When the catheter was removed there was some intraventricular bleed noted. This area addressed then a new catheter was connected to the existing valve. Valve tapped and csf obtained. Also checked the distal run-off and there was adequate run-off. Not enough room for brand name. Device used back in 2012 was a codman bactiseal ventricular catheter and distal catheter kit with bactiseal shunt system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3805843 |
| MDR Report Key | 3805843 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-04-21 |
| Date Facility Aware | 2014-04-21 |
| Report Date | 2014-05-01 |
| Date Reported to FDA | 2014-05-01 |
| Date Reported to Mfgr | 2014-05-01 |
| Date Added to Maude | 2014-05-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN BACTISEAL VENTRICULAR CATHETER |
| Generic Name | VENTRICULAR CATHETER FOR SHUNT |
| Product Code | GYK |
| Date Received | 2014-05-12 |
| Lot Number | CNHBBG |
| ID Number | REF. # 82-3072 |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-05-12 |