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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER SLIP SYRINGE; PISTON SYRINGE
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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER SLIP SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 990173
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd plastipak¿ luer slip syringe had a bent tip.The following information was provided by the initial reporter: "when preparing the medication, it is observed that the syringe tip has a deformity, making it impossible to connect the needle.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-28.H6: investigation summary : samples and photos received for investigation.Upon evaluation, luer appears damaged.A device history review was performed for the reported lot 1083027 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The process was evaluated and according to the investigation carried out, a possible root cause of the defect could have been a punctual entanglement caused in the conveyor belts after the siliconization step of the syringe.Corrective action taken include mapping and elimination of entanglement points in the equipment.H3 other text : see h10.
 
Event Description
It was reported that bd plastipak¿ luer slip syringe had a bent tip.The following information was provided by the initial reporter: "when preparing the medication, it is observed that the syringe tip has a deformity, making it impossible to connect the needle.".
 
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Brand Name
BD PLASTIPAK¿ LUER SLIP SYRINGE
Type of Device
PISTON SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12453438
MDR Text Key270839142
Report Number3003916417-2021-00283
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990173
Device Lot Number1083027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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