MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-26 for ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION 70-0060-222 SBRD-22-ENF manufactured by Xeridiem Medical Devices.
[107224935]
No patient information is available. Event date is estimated based upon report date (event date may be earlier). This mdr groups four complaints which are on the same model number and for the same issue. Entered date is earliest of the four. The remaining three were reported on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018. Model number is xeridiem part number. Catalog number is part number for cook medical, xeridiem's exclusive distributor for this device. Since lot number is unknown, expiration date and full udi are not known. Implant/explant dates are not known. Devices have not been returned on this group of four complaints (although a return on the 3/30/2018 complaint could still be possible). However, the reported issue is a known one. A follow-up report will only be provided if the device is returned on the fourth complaint and leads to a different finding from the known issue. (b)(6). Device return date listed is for first of the 4 complaints. The other three were reported on 3/12/2018, 3/19/2018 and 3/30/2018. Devices have not been returned for evaluation on this group of complaints (although a return could still be possible on the 3/30/2018 complaint). However, the issue is known. Date of manufacture cannot be determined since lot number is unknown. Known issue which is resolved by change recently cleared in k171347. Xeridiem is preently working through production implementation of this change.
Patient Sequence No: 1, Text Type: N, H10
[107224936]
The enfit caps and feeding port connections are breaking. There are small cracks in the caps themselves and the threaded flanges are breaking off. The patient is also using tools to get caps unstuck. The caps need to be tightened down hard or else they leak. The enfit that is glued into tube is breaking when patients try to wiggle the enfit connection out of the feeding ports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025851-2018-00010 |
| MDR Report Key | 7466580 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-03-02 |
| Date Mfgr Received | 2018-03-02 |
| Date Added to Maude | 2018-04-26 |
| 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 | MR. STEVE MURRAY |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON AZ 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal | 857143430 |
| Manufacturer Phone | 5208827794 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON AZ 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857143430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | PIF |
| Date Received | 2018-04-26 |
| Model Number | 70-0060-222 |
| Catalog Number | SBRD-22-ENF |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XERIDIEM MEDICAL DEVICES |
| Manufacturer Address | 4700 S. OVERLAND DRIVE TUCSON AZ 857143430 US 857143430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-26 |