PORT-A-CATH TITANIUM VENOUS 21-4000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-11 for PORT-A-CATH TITANIUM VENOUS 21-4000 manufactured by Pharmacia Deltec.

Event Text Entries

[3360] Pouch swelling and tip of port-a-cath broken off and in superior vena areadevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4987
MDR Report Key4987
Date Received1993-06-11
Date of Report1993-04-08
Date of Event1993-03-29
Date Facility Aware1993-03-29
Report Date1993-04-08
Date Reported to Mfgr1993-03-30
Date Added to Maude1993-06-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePORT-A-CATH
Product CodeLLD
Date Received1993-06-11
Model NumberTITANIUM VENOUS
Catalog Number21-4000
Lot Number18170A
ID NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Implant FlagY
Device Sequence No1
Device Event Key4690
ManufacturerPHARMACIA DELTEC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-06-11

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