MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for S-L BLUNT RETR BLADE 23X65MM ALUM NAVY S-0117 manufactured by Carefusion, Inc.
[117848747]
(b)(4). If further information becomes available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[117848748]
Blade broke during procedure. Failure occurred during patient use, no patient or user harm, no medical intervention. The patient was a (b)(6) year old, male, (b)(6) lbs, the o-ring around the blade where wooden handle attaches broke, the patient was stable after the event, the broken part fell into the body field and was retrieved under microscope with forceps, no additional medical procedures were required, yes the device was removed and replaced with another, the case went on and was successful, the procedure was an acdf c7-t1, completed as planned. Although asked if the facility reported the event to the fda, the answer was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1923569-2018-00020 |
| MDR Report Key | 7799331 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-08-20 |
| 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 | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 5 SUNNEN DRIVE |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | S-L BLUNT RETR BLADE 23X65MM ALUM NAVY |
| Generic Name | RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY |
| Product Code | GZT |
| Date Received | 2018-08-20 |
| Returned To Mfg | 2018-07-31 |
| Catalog Number | S-0117 |
| Lot Number | A17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 5 SUNNEN DRIVE ST. LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-20 |