MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-02-02 for SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT 4301CSP manufactured by Carefusion, Inc.
[98913139]
(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
[98913140]
It was reported via email: during a lp/chemo inj, the spinal needle leaked causing the chemo to spill outside the needle, leaving the patient with only a small unknown amount actually being injected to her spinal canal. This has compromised the patient's treatment plan. This was the first injection of several over a period of 2 months. Was there any patient harm or medical intervention required? Again, the patient's treatment plan for her cancer was compromised. Did the patient receive another injection at that time to receive the correct amount of chemo? Without knowing the actual amount of chemo that was injected, we were unable to repeat. Where specifically did the leak occur? At a connection site? Which one? The leak occurred at the square housing part of the needle. If effort to stop the leak, tubing was replaced, hub tightened, but the leak continued.
Patient Sequence No: 1, Text Type: D, B5
[108400059]
(b)(4). Follow up emdr for device evaluation. A sample tray was returned for sample evaluation however the leaking extension set was not included in the tray for evaluation. Consequently, the investigation was not able to evaluate the actual complaint sample. There were two additional, unopened trays that included extension sets that were tested against our quality standard. Both extension sets passed the quality inspection. Therefore, the reported failure mode could not be confirmed through the sample evaluation. A dhr review for lot 0001160994 did not identify any manufacturing defects or issues that may have contributed to the reported failure. Based on the complaint sample evaluations and the dhr review, no issues were identified that may have contributed to the reported failure mode. Consequently, the investigation was not able to identify a probable root cause for this complaint. Since no probable root cause was identified for the reported failure mode, the investigation was not able to identify any corrective or preventive actions for this complaint. The complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2018-00001 |
| MDR Report Key | 7238311 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-02-02 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2018-02-02 |
| 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 | 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 | 2018-02-02 |
| Catalog Number | 4301CSP |
| Lot Number | 0001160994 |
| 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 | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-02 |