MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-03 for TA KERRISON RONG. 8", 4MM BITE, 40 UP NL4291-84T manufactured by Carefusion, Inc.
[116537748]
(b)(4). On 09jul2018 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
[116537749]
Via email: instrument was defective. On 18jul2018 additional information: was the product received in this condition? No. If not, what was the product being used for when it was observed that the instrument was defective? Being used in surgery. Please confirm whether there was any patient impact. Delay in case, but no injury to the patient. What exactly is wrong with the instrument? Bending in the shaft. On 19jul2018 additional information: the case was delayed 5-10 minutes. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00015 |
| MDR Report Key | 7746660 |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-06-29 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2018-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | TA KERRISON RONG. 8", 4MM BITE, 40 UP |
| Generic Name | KERRISON RONGEURS |
| Product Code | HAE |
| Date Received | 2018-08-03 |
| Catalog Number | NL4291-84T |
| Lot Number | D17XME |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Brand Name | TA KERRISON RONG. 8", 4MM BITE, 40 UP |
| Generic Name | KERRISON RONGEURS |
| Product Code | HAE |
| Date Received | 2018-08-03 |
| Catalog Number | NL4291-84T |
| Lot Number | D17XME |
| 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. Other | 2018-08-03 |