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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON
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CARDINAL HEALTH 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON Back to Search Results
Model Number 8881512258
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event or Problem Description
Customer reports: when filling the syringes, there are black particles found in some of the syringes and white particles in other syringes from the lot.The customer sent the product to a 3rd party lab for analysis and the white fibers were identified as cellulose with silicone and oxygen-rich surface particles and the black fiber defects were identified as textile cotton fibers with spectral indications of silicone.
 
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Brand Name
12ML LUER LOCK TIP PHARM TRAY
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key12170317
Report Number9612030-2021-02986
Device Sequence Number4724741
Product Code FMF
UDI-Device Identifier10884521010970
UDI-Public10884521010970
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8881512258
Device Catalogue Number8881512258
Device Lot Number1909900864
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/06/2021
Initial Report FDA Received Date07/14/2021
Patient Sequence Number1
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