MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-02 for DYND140216 manufactured by Medline Industries Inc..
[143886742]
It was reported that on (b)(6) 2019, during placement of an indwelling catheter, the balloon that was placed in the patient ruptured within a few minutes of the balloon being inflated. After the balloon ruptured the catheter slid out and a new catheter insertion was required. The facility reported that prior to the initial catheter insertion the balloon of the catheter was pre-inflated to check the integrity of the balloon prior to insertion, contrary to the manufacturer's instructions for use. The patient did not require any surgical intervention after the reported incident. The facility reported that there was no serious injury identified, medical intervention required, or follow-up care needed. There was no change to the patient's plan of care and the patient has since been discharged from the hospital without incident. The actual device involved in the reported incident was returned for evaluation. The reported issue of a burst balloon was confirmed through visual inspection of the received sample. There is no definitive root cause for the tear at this time; however, based on the break pattern, it is suspected that the burst was caused by internal pressure within the balloon rather than an external force. There was no serious injury, follow-up medical care or additional medical intervention required related to the incident, however medical intervention to replace the initial catheter was necessary. No additional information is available. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted
Patient Sequence No: 1, Text Type: N, H10
[143886743]
It was reported that during placement of an indwelling catheter the balloon that was placed in the patient ruptured within a few minutes of the balloon of the catheter being inflated. A new urinary catheter was required to be inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00053 |
| MDR Report Key | 8575338 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-05-02 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRAY,FOLEY,SILVER,2-WAY,16FR,10ML,LF |
| Product Code | OHR |
| Date Received | 2019-05-02 |
| Returned To Mfg | 2019-04-19 |
| Catalog Number | DYND140216 |
| Lot Number | 19ABK969 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2019-05-02 |