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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 0935280
Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
 
Event Description
It was reported that the inside of the bulb syringe was dirty.
 
Event Description
It was reported that the inside of the bulb syringe was dirty.
 
Manufacturer Narrative
No physical sample was received; however, a photo sample was received for evaluation.The reported event was confirmed.During visual inspection, three small dots of foreign material were observed on the attached photo of the syringe, which had been circled with a black marker ink by the customer.Also, foreign yellowish material was observed on the neck of the green bulb next to the small dots.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "irrigation syringe bulb type non sterile".
 
Manufacturer Narrative
No physical sample was received; however, a photo sample was received for evaluation.The reported event was confirmed.During visual inspection, three small dots of foreign material were observed on the attached photo of the syringe, which had been circled with a black marker ink by the customer.Also, foreign yellowish material was observed on the neck of the green bulb next to the small dots.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "irrigation syringe bulb type non sterile".
 
Event Description
It was reported that the inside of the bulb syringe was dirty.
 
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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 Key7350171
MDR Text Key102854931
Report Number1018233-2018-00861
Device Sequence Number1
Product Code KYZ
UDI-Device Identifier10801741051378
UDI-Public(01)10801741051378
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,Followup
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/31/2022
Device Catalogue Number0935280
Device Lot NumberNGBV2814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2018
Date Manufacturer Received05/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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