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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE INTRAVASCULAR ADMINISTRATION SET.

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SMITHS HEALTHCARE MFG DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE INTRAVASCULAR ADMINISTRATION SET. Back to Search Results
Catalog Number 21-3271-24
Device Problem Fail-Safe Problem (2936)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site. Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
 
Event Description
User facility reported device was removed from use with patient and clinician was unable to lock needle into the protection device. No adverse health effects to patient reported.
 
Manufacturer Narrative
The reported 22g needle gripper micro® was returned for investigation. The device was received without its original packaging. During visual inspection a white discoloration was observed on the arm of the device. Also, damage was found on the back of the safety mechanism located on the needle arm. During functional testing, no audible click was heard when attempting to engage the needle into the safety mechanism. Upon examination, it was found that the safety mechanism of the needle did not function properly due to the damage found on the back of the needle arm. Investigation was unable to determine the root cause of the damage observed on the back of the needle arm. Mfr# clarification: new registration number 3012307300 (b)(4) has been received, however, this initial mdr was filed under the prior registration number 2183502 (b)(4).
 
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Brand NameDELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET.
Manufacturer (Section D)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave, calidad no.
parque industrial internaciona
tijuana, bc 22425
MX 22425
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave, calidad no.
parque industrial internaciona
tijuana, bc 22425
MX 22425
Manufacturer Contact
lisa perz
1265 grey fox rd.
st. paul, MN 55112
7633833074
MDR Report Key5830019
MDR Text Key50658694
Report Number2183502-2016-01627
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-3271-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2016
Was Device Evaluated by Manufacturer? Yes
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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