MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for BALLARD 1500 HEAT AND MOISTURE EXCHANGER 153 109381903 manufactured by Avanos Medical Inc..
[185023029]
The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. All information reasonably known as of 25-mar-2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc. Product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10
[185023030]
It was reported the closed suction catheter came apart while on the patient. There was no reported injury. Additional information received 04-mar-2020 stated it is not known how long the device was in place before the clinicians heard air escaping from the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2020-00051 |
| MDR Report Key | 9882553 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | COMMAND MEDICAL NICARAGUA SA |
| Manufacturer Street | KM 12.5 CARRETERA NORTE PARQUE INDUSTRIAL LAS MERCEDES |
| Manufacturer City | MANAGUA, MANAGUA |
| Manufacturer Country | NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLARD 1500 HEAT AND MOISTURE EXCHANGER |
| Generic Name | VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES |
| Product Code | BYD |
| Date Received | 2020-03-26 |
| Model Number | 153 |
| Catalog Number | 109381903 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |