MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL 4306C manufactured by Carefusion, Inc.
[74585707]
(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
[74585708]
Customer stated via email: failing extension tube. Additional information received (b)(6) 2017; they had experienced 2-3 leaking extension tubes from several trays from this lot. Unfortunately, they did not retain a sample as chemo was the media processed in these cases (they did not provide the actual chemo type, nor procedure being performed at the time). Chemo did make contact with at least one patient during the procedure but there was no harm communicated to me as a result of such contact.
Patient Sequence No: 1, Text Type: D, B5
[86922629]
(b)(4). Ten unopened trays were received for analysis. Each tray contains one 5? Extension set. A functional test was performed by connecting the distal end of each extension set to an adaptor, and clamping the tubing closed. A 45 psi of water was applied, and the tubing/luer adaptor joint was observed for leaks. No leaks were observed in the ten samples, therefore, the reported defect was not confirmed. A device history record report was completed for lot 0001029408. No issues were found. The extension set is a supplied component of the tray. Bd has taken a proactive stance and initiated a capa (corrective action preventive action) in which a scar (supplier corrective action request) was sent to the supplier in addition to a heightened inspection and testing of the incoming product from this vendor. The manufacturing plant is continuing to monitor this issue to identify the need for any further actions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2017-00287 |
| MDR Report Key | 6543606 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-04-13 |
| Date Added to Maude | 2017-05-04 |
| 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 | LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-05-04 |
| Returned To Mfg | 2017-04-19 |
| Model Number | 4306C |
| Lot Number | 0001029408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-05-04 |