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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SYRINGE
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SYRINGE Back to Search Results
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); 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 device was not returned.
 
Event Description
It was reported that the plastic hub broke off the needle.All pieces were accounted for.No medical intervention was reported.The complainant advised via email on 24-may-2019 that she believes this may have been an isolated incident due to some user error.The complainant will follow-up with nurse and revert back.The complainant advised via email on 10-june-2019, that there are no additional concerns at this time.
 
Event Description
It was reported that the plastic hub broke off the needle.All pieces were accounted for.No medical intervention was reported.The complainant advised via email on (b)(6) 2019 that she believes this may have been an isolated incident due to some user error.The complainant will follow-up with nurse and revert back.The complainant advised via email on (b)(6) 2019, that there are no additional concerns at this time.
 
Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event."sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act in so far as adequate directions for common uses there of are known to the ordinary individual." product catalog number z36 is deemed by appropriate subject matter experts (sme) to be within this definition.
 
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Brand Name
UNKNOWN SYRINGE
Type of Device
UNKNOWN SYRINGE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8696196
MDR Text Key148277684
Report Number1018233-2019-03111
Device Sequence Number1
Product Code KYZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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