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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLES SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLES SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-3367-24
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2016
Event Type  malfunction  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a deltec® gripper plus® safety needle could not be retracted at all. The staff had to remove the needle without engaging the sharp portion. No patient injury was reported. See mfr: 3012307300-2016-00061.
 
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Brand NameDELTEC® GRIPPER PLUS® SAFETY NEEDLES
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6017044
MDR Text Key57083568
Report Number3012307300-2016-00062
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K072657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 09/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Catalogue Number21-3367-24
Device Lot Number36X466
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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