MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-02-06 for BALLARD MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS, 16 F, DSE, MDI 240168-5 N/A manufactured by Avanos Medical Inc..
[180028197]
The sample is reported to be available, but has not yet been received by the manufacturer. The device history record for lot m19168t802 was reviewed and the product was produced according to product specifications. All information reasonably known as of 04 feb 2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical inc. Represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.. 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 complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180028198]
It was reported that during tracheal aspiration, the catheter moves out of place, causing a leak which caused the sleeve to inflate. No reported injury to the patient. No further information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030647-2020-00005 |
| MDR Report Key | 9675914 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-02-06 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-06-24 |
| Date Added to Maude | 2020-02-06 |
| 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 MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS, 16 F, DSE, MDI |
| Generic Name | VAP CLOSED SUCTION CATHETERS & ACCESSORIES |
| Product Code | BSY |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 240168-5 |
| Catalog Number | N/A |
| Lot Number | M19168T802 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-06 |