MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-05 for BIOPSY TRAY SOFT TISSUE W/O NEEDLE 4382A manufactured by Carefusion.
[27524167]
(b)(4). Upon carefusions investigation, a follow up emdr submission will be done.
Patient Sequence No: 1, Text Type: N, H10
[27524168]
Needle stick needle using our foam needle stop. He indicates that the plastic surrounding the foam is thinner than in the past and insufficient to prevent injury. It was confirmed that the doctor was harmed. (b)(6) 2015 additional response-the needle was contaminated therefore provider required post needle stick blood draw, he suffers from no health changes at this time lot number is not available however needle holder is.
Patient Sequence No: 1, Text Type: D, B5
[32297273]
(b)(4). One foam needle stop was returned for analysis. The plastic tray to which the stop is attached was cut so that only the section in question was returned. The plastic surrounding the foam stop sample was visually inspected for a puncture, and no defect was found. (b)(4). No adverse trend was detected. Sample analysis could not confirm the reported failure mode. A lot number for the product was not provided with the complaint, so the device history could not be investigated. Trending data for the reported failure did not indicate a negative trend. Therefore, a root cause could not be established. In addition: the verbatim of the customer indicates that the tray had historically been used to assist the foam needle stop in preventing injury. Please know the intended use of the tray is strictly for containing the contents, not preventing injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2015-00217 |
| MDR Report Key | 5128474 |
| Date Received | 2015-10-05 |
| Date of Report | 2015-11-30 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-09-11 |
| Date Added to Maude | 2015-10-05 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPSY TRAY SOFT TISSUE W/O NEEDLE |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2015-10-05 |
| Returned To Mfg | 2015-10-02 |
| Model Number | 4382A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-05 |