MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for DISCONTINUED-ALT NL6960-1 manufactured by Carefusion, Inc.
[110583279]
Pr # (b)(4) on (b)(6) 2018 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
[110583280]
Via email: distal tip of instrument broke, the event did not occur during patient use, no patient or user harm, no medical intervention. On (b)(6) 2018: the customer reported, no visible lot number, the tip broke while being utilized during a surgery. The device will be shipped via ups tomorrow. On (b)(6) 2018: no patient injury or intervention, nothing reported outside of the instrument breaking, patient's medical status after the event was stable. Although many other questions were asked, the customer was unable to provide answers. On (b)(6) 2018 additional information: could you please clarify if device broke during surgery or not. We are trying to determine reportability, and we would like to know if any piece of the instrument fell into the patient, and if so was an x-ray used to determine where it was? The device broke while the doctor was performing surgery. There was no patient harm. There were no x-rays. Do you know if any part fell into the patient, or would you be able to find out that information? Very unlikely anyone will remember because it was such a long time ago. No further information available. Pr # (b)(4) on (b)(6) 2018 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: D, B5
| Report Number | 1423507-2018-00011 |
| MDR Report Key | 7569283 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2018-06-05 |
| 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 | DISCONTINUED-ALT NL6960-1 |
| Generic Name | NONPOWERED NEUROSURGICAL INSTRUMENT |
| Product Code | HAO |
| Date Received | 2018-06-05 |
| Catalog Number | NL6960 |
| Lot Number | XHER04 |
| Operator | PHYSICIAN |
| 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 | 2018-06-05 |