MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-30 for DAR 351/5856 manufactured by Mallinckrodt Dar Srl.
[177162231]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177162232]
According to the reporter, the device had a crack. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2936999-2020-00071 |
MDR Report Key | 9650443 |
Report Source | FOREIGN,USER FACILITY |
Date Received | 2020-01-30 |
Date of Report | 2020-03-05 |
Date of Event | 2020-01-02 |
Date Mfgr Received | 2020-02-11 |
Date Added to Maude | 2020-01-30 |
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 | 3 |
Manufacturer Contact | AVI KLUGER |
Manufacturer Street | 5920 LONGBOW DRIVE |
Manufacturer City | BOULDER CO 80301 |
Manufacturer Country | US |
Manufacturer Postal | 80301 |
Manufacturer Phone | 2034925563 |
Manufacturer G1 | MALLINCKRODT DAR SRL |
Manufacturer Street | VIA GIACOMO BOVE 2/4/6/8 |
Manufacturer City | MIRANDOLA 41037 |
Manufacturer Country | IT |
Manufacturer Postal Code | 41037 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | DAR |
Generic Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
Product Code | CAH |
Date Received | 2020-01-30 |
Returned To Mfg | 2020-01-31 |
Model Number | 351/5856 |
Catalog Number | 351/5856 |
Lot Number | 19C1252FAX |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MALLINCKRODT DAR SRL |
Manufacturer Address | VIA GIACOMO BOVE 2/4/6/8 MIRANDOLA 41037 IT 41037 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-30 |