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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939032804080
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 10/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that the package was labelled incorrectly.During unpacking, it was noted that there was a 8.0mm label on the front of the box and a small 3.0mm label on the side of the box.No patient was involved in this case.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling carton with the carton label.The closure strip is opened.Inside of the carton was the empty opened pouch for the sterling device and the dfu.The catheter was not returned for analysis.The carton label was examined.The size that is on the front of the carton label shows 8.0mm x 40mm x80cm, but the size on the spine of the label appears to be 3.0mm x40mm x80cm.There appears to be small scratches/wrinkles around the 3.00mm lettering.The investigation conclusion is related to a problem with the labeling.(b)(4).
 
Event Description
It was reported that the package was labelled incorrectly.During unpacking, it was noted that there was a 8.0mm label on the front of the box and a small 3.0mm label on the side of the box.No patient was involved in this case.
 
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Brand Name
STERLING¿
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7025760
MDR Text Key92750623
Report Number2134265-2017-11179
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K053116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/05/2020
Device Model NumberH74939032804080
Device Catalogue Number39032-80408
Device Lot Number20732894
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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