MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for CENTURION PEDI CATH KIT 5FR CKF290L manufactured by Medline Industries, Inc..
[184266362]
Attempted to catheterize a pediatric patient with three separate 5 french pediatric catheter kits with lot # 2019092390. Urethra was visualized and there were no apparent challenges with the patients anatomy or holding of the patient. Catheters were floppier than normal, not stiff enough to advance. The catheter insertion in the tube was far looser than expected which could cause issues with sterility. Gloves were of very poor quality. As a result patient was bagged for a urine specimen- which was not an ideal sampling. The poor quality of these kits caused repeated attempts and discomfort for the patient and parent. Opened several other kits with lot # 2018102990 and the catheter was just slightly larger and stiffer. Catheter was more securely anchored in tube. Gloves were still of poor quality.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859617 |
| MDR Report Key | 9859617 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-02 |
| Report Date | 2020-03-05 |
| Date Reported to FDA | 2020-03-05 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION PEDI CATH KIT 5FR |
| Generic Name | CATHETER, STRAIGHT |
| Product Code | EZD |
| Date Received | 2020-03-20 |
| Catalog Number | CKF290L |
| Lot Number | 2019092390 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |