MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT 4301CSP manufactured by Carefusion, Inc.
[69019203]
(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69019204]
Customer stated via email: advanced practice providers on my staff have had multiple episodes of leaking from tubing in our current lp kits. I am very concerned that there is a defect in the tubing. This is a patient safety issue. And also a staff safety issue since chemotherapy is administered through this tubing. We have filed incident reports. Additional information received 09feb2017: this has happened multiple times to multiple different providers. I have had at least a dozen reports. All instances have occurred during patient use. As far as i know, there was no patient injury, however amount of chemotherapy administered could have been affected and staff members almost certainly had skin contact with chemotherapy. I do not believe we have any samples but can check with my staff.
Patient Sequence No: 1, Text Type: D, B5
[75230880]
(b)(4) follow up emdr submission for device evaluation. A sample was not returned for analysis. A device history record review was performed for lot 0001020794. No issues were found, indicating that manufacturing procedures were properly followed, and subsequent quality inspections were passed. Although the defect could not be confirmed via sample analysis, leaking extension sets have been identified as an issue. The investigation identified the failure as a material defect. The extension set is a supplied component of the trays and a scar (supplier corrective action request) was sent to the supplier. Additionally bd has taken a proactive stance and initiated a capa (corrective action preventive action). This includes a heightened inspection and testing of our incoming product from this vendor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2017-00272 |
| MDR Report Key | 6367723 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-05-02 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2017-03-01 |
| 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 | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-03-01 |
| Model Number | 4301CSP |
| Lot Number | 0001020794 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |