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 2020-01-09 for BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 8 F, Y-ADAPTER 198 109382603 manufactured by Avanos Medical Inc..
[178729903]
The device history record for the reported lot number, m19120t502, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. The product involved in the report has been returned and is being processed for evaluation. All information reasonably known as of 08-jan-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).
Patient Sequence No: 1, Text Type: N, H10
[178729904]
It was reported that when the closed suction catheter was turned on it was not "closing off the suction to the system. " the device was had to be replaced and was in use for less than 48 hours. There was no reported injury. Additional information received 16-dec-2019 stated this incident occurred on late on (b)(6) 2019 or the early hours of the morning on (b)(6) 2019. Since the patient did not have any chest rise, she was taken off the ventilator several times to be manually bagged until the issue was properly identified. Once the issue of the failure was identified the device was changed out and the patient was able to go back on the ventilator without any issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030647-2020-00002 |
| MDR Report Key | 9568496 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-04-30 |
| Date Added to Maude | 2020-01-09 |
| 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 | AVENT S DE RL DE CV |
| Manufacturer Street | CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053 |
| Manufacturer City | MAGDALENA, CP |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 8 F, Y-ADAPTER |
| Generic Name | VAP CLOSED SUCTION CATHETERS & ACCESSORIES |
| Product Code | BSY |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2019-12-23 |
| Model Number | 198 |
| Catalog Number | 109382603 |
| Lot Number | M19120T502 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-09 |