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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML14GA 1-1/4IN PERFUSION

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BECTON DICKINSON, S.A. SYRINGE 50ML14GA 1-1/4IN PERFUSION Back to Search Results
Catalog Number 300136
Device Problem Leak/Splash (1354)
Patient Problems Death (1802); Exsanguination (1841)
Event Date 11/26/2018
Event Type  Death  
Manufacturer Narrative
Date of death: unknown. The actual date of death is unknown. (b)(6) 2018 has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or physical samples that display the reported condition were available for investigation. A device history review could not be completed as no batch number was provided. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no information or sample was provided. This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences. Based on no sample, the investigation concluded, bd was not able to verify the indicated failure. Root cause description: based on the available information we are not able to identify a root cause at this time. Rationale: bd was not able to duplicate or confirm the customer¿s indicated failure as no information or sample was provided.
 
Event Description
It was reported that syringe 50ml perfusion was disconnected during use. This caused a considerable loss of blood, which led to death. The following information was provided by the initial reporter: disconnection of the luer-lock connection bd insulin syringe 50ml, considerable blood loss which led to death. Samples were secured by the police. Semi-stationary treatment case multimorbid, tracheotomized patient. Infection status: (b)(6). The (b)(6) trade inspectorate asked us to report this incident. Unfortunately, we cannot give any more precise information about the affected samples, as these were ensured by the police. There is an expert opinion, which we unfortunately do not have. The (b)(6) criminal police is conducting the case under the (b)(4). : by (b)(4).
 
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Brand NameSYRINGE 50ML14GA 1-1/4IN PERFUSION
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9723256
MDR Text Key179992471
Report Number3003152976-2020-00068
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300136
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2020 Patient Sequence Number: 1
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