MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for PEDI CATH KIT, 5FR, SOFT WITH SURGICAL LUBE CKF155L manufactured by Centurion Medical Prdoucts / Medline Industries, Inc..
[184178539]
As part of my work related to pt care and supply logistics in a military hosp, i noticed a centurion pediatric catheter kit 5fr soft with surgical lube appeared to have mold and yellow/brown dried liquid on the inside of the package. The package is unopened and not expired; exp date is set for 10/31/2020. I have not opened the packet to investigate, but i believe that the internal packet of iodine was broken and leaked out. This allowed for a growth to start inside the otherwise sterile package. The rest of the lot seemed uncontaminated. The lot number is 2018120690. The reorder number for the centurion medical product is ckf155l. I was recently informed to create this report regarding the event. Fda safety report id#. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093804 |
| MDR Report Key | 9847754 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-15 |
| Date of Event | 2020-01-12 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDI CATH KIT, 5FR, SOFT WITH SURGICAL LUBE |
| Generic Name | TRAY, CATHETRIZATION, STERILE URETHRAL WITH OR WITHOUT CATHETER (KIT) |
| Product Code | FCM |
| Date Received | 2020-03-17 |
| Model Number | CKF155L |
| Lot Number | 2018120690 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRDOUCTS / MEDLINE INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |