MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-10-04 for SAFETY DRAIN CLOSED VENTILATOR CIRCUIT DRAIN 131 manufactured by Kimberly-clark/ballard Medical.
[15161241]
A user facility reported one occurrence, in one day, that the "y" portion at the top of the safety drain device fell off from one pt. When the therapist was replacing the device, he picked up another safety drain and that device fell apart. The supervisor had all pts checked that had a safety drain in use and found two more safety drains that were leaking and fell apart as they were removed. The facility state that there was no pt injury, harm or individuals adversely affected related to the four incidents. Kimberly-clark/ballard medical has no first hand knowledge of the allegations, but is relayinginfo rec'd from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
[15170039]
The user facility did not retain any of the devices involved in the reported incidents. The user facility cited ten prod lot #s that remained in the inventory at the time of the incidents. However, two of those lot #s were not for safety drain prod. At this time, we are awaiting return of the user facility's inventory. Unused prod that is returned from the facility will be evaluated to determine if there are other devices that have the potential for the "y" to separate from the top of the safety drain. In addition, safety drain catalog # 131 from current inventory will also be evaluated. This is the first report that the safety drain's top portion of the "y" had come apart. The potential health risk from this type of incident was determined to be none to negligible. A supplemental report will be submitted when eval data are available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719891-2004-00040 |
| MDR Report Key | 904498 |
| Report Source | 06 |
| Date Received | 2004-10-04 |
| Date of Report | 2004-10-04 |
| Date of Event | 2004-09-13 |
| Date Mfgr Received | 2004-09-13 |
| Date Added to Maude | 2007-08-30 |
| 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 | 0 |
| Manufacturer Contact | SALLY HERRICK |
| Manufacturer Street | 12050 LONE PEAK PARKWAY |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8015235105 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY DRAIN CLOSED VENTILATOR CIRCUIT DRAIN |
| Generic Name | DRAIN TEE (WATER TRAP) |
| Product Code | BYH |
| Date Received | 2004-10-04 |
| Model Number | NA |
| Catalog Number | 131 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 879307 |
| Manufacturer | KIMBERLY-CLARK/BALLARD MEDICAL |
| Manufacturer Address | 12050 LONE PEAK PKWY. DRAPER UT 84020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-04 | |
| 2 | 0 | 2004-10-04 |