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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 21-2766-24
Device Problems Retraction Problem (1536); Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2016
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. (b)(4).
 
Event Description
It was reported that a deltec® gripper plus® safety needle safety feature to retract the needle failed. Upon inspection, it was noted that the base of the safety mechanism was "seared together," which did not allow needle to retract. No patient or clinician injury was reported. See mfr: 3012307300-2016-00381.
 
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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 Key6125454
MDR Text Key60869475
Report Number3012307300-2016-00380
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 10/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2021
Device Catalogue Number21-2766-24
Device Lot Number36X1106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2016
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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