MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for BALLENGER SWIVEL KNIFE STR BLADE 2MMWIDE RH762 manufactured by Carefusion, Inc.
[118102178]
(b)(4). On 01aug2018 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[118102179]
Customer reported via telephone call: the instrument broke during a septoplasty. No patient harm. Customer requesting info on life expectancy of instrument. On 02aug2018 additional information was communicated over the phone: 1. What was the procedure that was being performed? Septoplasty. 2. Did any part the instrument fall into the patient? S body, and if so how was it retrieved? Yes, a piece of the instrument fell into the patient. 3. Was there a medical procedure performed to verify if the instrument was in the patient? S body, such as an x-ray? Yes, an x-ray was taken to verify where the piece was located. 4. What was the patient? S outcome? The piece was removed, and the patient is doing well. 5. Was the procedure completed as planned? The procedure was completed as planned. 6. Can you please send all parts of the instrument for evaluation? Yes. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00017 |
| MDR Report Key | 7804843 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-07-31 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2018-08-22 |
| 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 | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BALLENGER SWIVEL KNIFE STR BLADE 2MMWIDE |
| Generic Name | KNIFE, NASAL |
| Product Code | KAS |
| Date Received | 2018-08-22 |
| Catalog Number | RH762 |
| Lot Number | XODV08 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-22 |