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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. DELTEC GRIPPER PLUS® SAFETY NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2965-24
Device Problem Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/19/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and 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 during removal of gripper plus, a needle stick occurred. While the nurse was removing the gripper plus, the needle disengaged from safety and pricked the nurse's index finger. There were no adverse health outcomes encountered by the patient, however, the protocol for accidental blood exposure were implemented for the nurse.
 
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Brand NameDELTEC GRIPPER PLUS® SAFETY NEEDLE
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.
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6036283
MDR Text Key57702513
Report Number3012307300-2016-00105
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Catalogue Number21-2965-24
Device Lot Number36X634
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 Received09/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2016 Patient Sequence Number: 1
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