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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ SYRINGES WITH NEEDLES LUER SLIP SAFETY ENGINEERED SYRINGE AND NEEDLE

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BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ SYRINGES WITH NEEDLES LUER SLIP SAFETY ENGINEERED SYRINGE AND NEEDLE Back to Search Results
Catalog Number 990147
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported in 10 bd¿ syringes with needles luer slip syringes that during use of the insulin preparation and application process, when removing the shield/protective cap the needle detached from the rest of the syringe. "she also informs that due to this it was necessary to re-insert the needle. The client mentions that in the moment the insulin is applied in her mother, the insulin "explodes" between the junction of the needle and the syringe body. Note: the client is able to perform the aspiration of the insulin, but when performing the application, it identifies a pressure on the plunger, which assists in the occurrence of this "explosion" of insulin. Another problem identified was that among the 10 syringes, 2 of these got attached in the skin of their mother. The explosion of the insulin is related to its leakage through the syringe. The needle that separated and got attached to skin was removed by hands. ¿ found during use. No serious injury or medical interventions needed.
 
Manufacturer Narrative
Investigation results: the sample provided was analyzed and it was not possible to confirm the defect. (separates - cannula - hub¿ / ¿leakage ¿ hub / difficult / unable to operate). The retention batch was checked and none was found clogged. Bd was not able to confirm/ reproduce the incident in question. The batch history analysis was performed, the quality notifications and maintenance records verified, and there is no quality notifications related with this batch. The batch complained was manufacturing during october 02nd 2017 to october 06th 2017. The inspections carried out on the sema01¿ semo01 ¿ semo02 ¿ seeb06 machine were checked and no records of this defect were found. The current controls for detecting this kind of failure is done by control plan. Qn/ maintenance review: there are no quality notification (qn) or maintenance report records that could lead to this issue for the batches involved in this complaint. Based on the severity and occurrence a capa is not required at this moment. Corrections are not applied, because the deviation cannot be confirmed.
 
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Brand NameBD¿ SYRINGES WITH NEEDLES LUER SLIP
Type of DeviceSAFETY ENGINEERED SYRINGE AND NEEDLE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer (Section G)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7323655
MDR Text Key102029181
Report Number3003916417-2018-00021
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K010188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Catalogue Number990147
Device Lot Number7270801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2017
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: 03/08/2018 Patient Sequence Number: 1
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