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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE; SYRINGE, ANTISTICK

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TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE; SYRINGE, ANTISTICK Back to Search Results
Catalog Number 102-N251S
Device Problem Use of Device Problem (1670)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/30/2016
Event Type  Injury  
Manufacturer Narrative
Udi - not required for the reported product code/lot number combination.(b)(4).The actual device was not returned, however, 39 unused samples from the reported lot were returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, the 39 returned unused samples, and retention samples from the reported product code/lot number combination.A visual and sensory inspection of the 39 returned unused samples revealed no defects.A visual and sensory inspection of the retention samples revealed no defects.Functional testing was conducted on the 39 unused samples and retention samples and could not reproduce the reported failure.A review of the manufacturing records was conducted with no relevant findings.Prior to shipment, qc conducts outgoing visual, functional, and sensory inspection and all samples for the reported complaint lot passed.See mdr no.3003902955-2017-00006 for the second event reported for a different patient.The investigation results verified that the 39 unused samples and the retention samples were the normal product.There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively determined.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.Exemption number e2015017.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.
 
Event Description
It was reported from the (b)(4) representative that "the safety cap does not snap into place over the needle, it drifts away from the needle.We've had two nurses stuck with safety hypodermic needles in the last month." additional information was provided on (b)(6) 2017 by the rn: "nurse delivered injection without incident, and was attempting to close safety needle with her thumb, resulting in a needle stick to 3rd digit, left hand." we discussed activating on hard flat surface as indicated in this device ifu.The rn stated she would remind the staff to follow the proper technique.On (b)(6) 2017 nurse returned to work after protocol testing/treatment completion.Post exposure testing was (b)(6) for infectious disease.On (b)(6) 2017 the user facility reported that the nurse received post exposure blood testing, and immunization (specific on immunization (b)(6) series initiated due to test results - immunity not adequate) then returned to work.
 
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Brand Name
MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE
Type of Device
SYRINGE, ANTISTICK
Manufacturer (Section D)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
binan, laguna
RP 
Manufacturer (Section G)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
binan, laguna, reg. no. 3003902955
RP  
Manufacturer Contact
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset 08873
8002837866
MDR Report Key6407246
MDR Text Key70017804
Report Number3003902955-2017-00005
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue Number102-N251S
Device Lot Number160505B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/15/2017
Initial Date FDA Received03/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PREFILLED MEDS VIALS : FLU SHOTS, ETC.; PREFILLED MEDS VIALS : FLU SHOTS, ETC.
Patient Outcome(s) Required Intervention;
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