DAR 331/5661

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for DAR 331/5661 manufactured by Mallinckrodt Dar Srl.

Event Text Entries

[115767994] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[115767995] According to the reporter, postoperatively, the unit's extension tube connection port was ruptured. It was also reported that air leaked from the suction tube and endotracheal tube could be carefully observed and was found that the breathing circuit chain interface was cracked and was replaced immediately. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[132425931] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2936999-2018-00476
MDR Report Key7735069
Date Received2018-07-31
Date of Report2019-02-19
Date of Event2018-07-15
Date Mfgr Received2019-01-24
Device Manufacturer Date2017-04-20
Date Added to Maude2018-07-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAVI KLUGER
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone3035306582
Manufacturer G1MALLINCKRODT DAR SRL
Manufacturer StreetVIA GIACOMO BOVE 2/4/6/8
Manufacturer CityMIRANDOLA 41037
Manufacturer CountryIT
Manufacturer Postal Code41037
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDAR
Generic NameCONNECTOR, AIRWAY (EXTENSION)
Product CodeBZA
Date Received2018-07-31
Model Number331/5661
Catalog Number331/5661
Lot Number17C1787FAX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMALLINCKRODT DAR SRL
Manufacturer AddressVIA GIACOMO BOVE 2/4/6/8 MIRANDOLA 41037 IT 41037


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-31

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