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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 02/03/2020
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 the black foreign material was found.Per additional information received via email on 17 feb 2020 from ibc representative, it seemed that the foreign material was found inside the syringe.
 
Event Description
It was reported that the black foreign material was found.Per additional information received via email on 17 feb 2020 from ibc representative, it seemed that the foreign material was found inside the syringe.
 
Manufacturer Narrative
The reported event was unconfirmed since the product met specifications.Visual evaluation of the returned sample noted one unopened (in original packaging), unused irrigation bulb syringe.It was noted that there was a 0.40 sq mm, brown, cardboard-like speck within the syringe body.This foreign material meets the specification of "loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16¿ per the dirt estimation chart." a device history record review was not required per the investigation.A labeling review was not performed because labelling could not have prevented the reported failure.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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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 Key9745450
MDR Text Key184147884
Report Number1018233-2020-01271
Device Sequence Number1
Product Code KYZ
UDI-Device Identifier00801741049255
UDI-Public(01)00801741049255
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 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Catalogue Number0035280
Device Lot NumberNGDP2873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Date Manufacturer Received03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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