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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2768-24
Device Problem Fail-Safe Problem (2936)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
Customer contact phone number: (b)(6).
 
Event Description
It was reported that the needle broke apart in the area within the hinge of the deltec gripper plus.More specifically this was observed when pulling and releasing the safety mechanism.The product problem did not cause or contribute to any adverse health effects for the patient.
 
Manufacturer Narrative
Twelve pictures were attached and it could be seen that the safety mechanism was broken and the needle was out of it.The complaint is confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
DELTEC
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11672536
MDR Text Key245749499
Report Number3012307300-2021-03177
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number21-2768-24
Device Lot Number4027302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/19/2021
Initial Date FDA Received04/15/2021
Supplement Dates Manufacturer Received05/31/2021
Supplement Dates FDA Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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