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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
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C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE Back to Search Results
Catalog Number 0035280
Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that foreign material was found inside the syringe.
 
Event Description
It was reported that the foreign material found inside the syringe.
 
Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.Visual inspection noted that one irrigation syringe was received without the original packaging.Visual evaluation noted that 3 white specs (measuring 0.20, 0.25, 0.20 sq.Mm) were found in the bulb outside the syringe body.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to defective/ contaminated components from suppliers.The product was not used for diagnosis or treatment.The product had failed to meet the specifications, and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to labeling could not have prevented the reported failure.
 
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Brand Name
BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
Type of Device
IRRIGATION SYRINGE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10159189
MDR Text Key195722767
Report Number1018233-2020-03888
Device Sequence Number1
Product Code KYZ
UDI-Device Identifier00801741049255
UDI-Public(01)00801741049255(10)
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number0035280
Device Lot NumberNGDV1639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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