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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYE¿ AUTOGUARD INSULIN SYRINGE

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BECTON DICKINSON UNSPECIFIED BD INSYE¿ AUTOGUARD INSULIN SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Exposure to Body Fluids (1745)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Date of event: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. A sample is not available for evaluation. However, a no sample investigation will be completed. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that after using an unspecified bd insye¿ autoguard, the needle retracted but blood splattered and got on the providers face and eyes. The provider was sent to the hospital for follow up but no additional information has been provided.
 
Manufacturer Narrative
Device/batch history record review could not be performed as the lot number was not provided. A search of the qn / sap database could not be done; no lot and part numbers were provided for this incident. The peura (end user risk analysis) was analyzed to determine the risk to customer. The analysis showed that due to low occurrence, current risk is acceptable. Observations and testing could not be performed because units were not received for investigation. Conclusions: the defect blood excess/splash/spill/exposure as stated in the description of the complaint could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing. Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the reported defect. A root cause could not be identified. A formal corrective action will not be initiated at this time. Customer complaint trends are evaluated on a quarterly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Event Description
It was reported that after using an unspecified bd insye¿ autoguard, the needle retracted but blood splattered and got on the providers face and eyes. The provider was sent to the hospital for follow up but no additional information has been provided.
 
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Brand NameUNSPECIFIED BD INSYE¿ AUTOGUARD
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7565438
MDR Text Key109931668
Report Number2243072-2018-00336
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/04/2018 Patient Sequence Number: 1
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