MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for GOLD 2WAY PED SIL 3CC 8F 180003080 manufactured by Teleflex Medical.
[94236647]
(b)(4). The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[94236648]
Issue reported: boy, (b)(6) year old, arrived at the hospital with septic shock. The situation was stabilized and a catheter was placed according record. A cuff test was performed by inflation with air before introduction of the catheter. At the moment to introduce the catheter the same progressed normally, catheter of latex, putting 4ml of distilled water. Placed the catheter on saturday and on monday they noted that there was leakage of urine on diaper when they went change the diaper. They tried to deflate the cuff and it was not presented with reflux. The syringe had resistance to pulling the piston so it was cut with medical orientation to verify if the same was without air. They inserted a needle 40x12 to try to withdraw the possible air from the balloon, but the attempt was unsuccessful. They took the patient to ultrasound where they noted the balloon was in the bladder floating and it was inflated. After several attempts to deflate the cuff, they called a surgeon who performed a supra pubic puncture guided by ultrasound to burst the balloon. The patient's condition is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2017-00257 |
| MDR Report Key | 7070983 |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2017-11-30 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOLD 2WAY PED SIL 3CC 8F |
| Product Code | KOB |
| Date Received | 2017-11-30 |
| Returned To Mfg | 2017-12-06 |
| Catalog Number | 180003080 |
| Lot Number | 16J12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-30 |