ADAPTOR,CUFF,22MM ID 1421

MAUDE Adverse Event Report

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 2017-09-07 for ADAPTOR,CUFF,22MM ID 1421 manufactured by Teleflex Medical.

Event Text Entries

[85130554] (b)(4). Visual inspection of the product involved in the complaint was performed on the returned sample. It is noted that the product was not received in its original packaging. It can be observed a damage issue on the adaptor. No other issues were found. A device history record review showed that there were no issues related to the reported failure mode, neither on the product nor its components, during the manufacture of this material. Customer complaint is confirmed based on sample provided. However, there is not sufficient evidence to determine this issue originated during manufacturing process. The root cause for the condition reported could not be identified. No corrective actions can be assigned. A conclusion code could not be assigned. The complaint is confirmed but the root cause could not be identified. Teleflex will continue to monitor and trend for reports of this issue.
Patient Sequence No: 1, Text Type: N, H10


[85130555] Customer complaint alleges they "are having issues with carefusion or teleflex products depositing shards of plastic in the circuits. " alleged defect noted during use. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2017-00336
MDR Report Key6848466
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-09-07
Date of Report2017-08-17
Date of Event2017-05-16
Date Mfgr Received2017-08-17
Device Manufacturer Date2016-12-15
Date Added to Maude2017-09-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLINDA WOODALL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9196942566
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADAPTOR,CUFF,22MM ID
Generic NameCONNECTOR, AIRWAY (EXTENSION)
Product CodeBZA
Date Received2017-09-07
Returned To Mfg2017-08-04
Catalog Number1421
Lot Number74M1602188
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-07

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