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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUTURE DIAGNOSTICS LLC CARE TOUCH LUER SLIP 3 ML DISPOSABLE SYRINGE SYRINGE PISTON

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FUTURE DIAGNOSTICS LLC CARE TOUCH LUER SLIP 3 ML DISPOSABLE SYRINGE SYRINGE PISTON Back to Search Results
Model Number CTSLS3
Device Problems Particulates (1451); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
Event Type  malfunction  
Event Description
We purchased caretouch 3ml luer slip syringes (ndc# (b)(4)), lot # 170522 from careline medical supplies. We were given a certificate of compliance that the syringes were sterile and compliant with fda mfg standards. Upon receiving the syringes, mold was noticed growing within one of the individually sealed syringes, as well as evidence of mold within the carton containing all the syringes as well as the outer shipper carton. While investigating other cartons and syringes from this lot number for signs of mold, it was also noted that 7 syringes were found to contain micro particles of black specks within the sealed syringe bags which proved that they are not sterile.
 
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Brand NameCARE TOUCH LUER SLIP 3 ML DISPOSABLE SYRINGE
Type of DeviceSYRINGE PISTON
Manufacturer (Section D)
FUTURE DIAGNOSTICS LLC
MDR Report Key8231174
MDR Text Key133072609
Report NumberMW5082951
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/07/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCTSLS3
Device Lot Number170522
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/08/2019 Patient Sequence Number: 1
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