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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
Event Type  malfunction  
Manufacturer Narrative
"there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1711281, medical device expiration date: 10/31/2022, device manufacture date: 11/30/2017. Medical device lot #: 1709230, medical device expiration date: 08/31/2022, device manufacture date: 09/11/2017. 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 that the rubber stopper of the bd plastipak¿ concentric luer lock syringe was detached. It is unclear when the findings occurred. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Investigation summary: as no samples were returned for the reported issue, a sample investigation could not be completed. A device history record review for the provided lot numbers, 1711281 and 1709230, did not reveal any deviations or issues during production that could have contributed to the reported defect. Final products of lots 1711281 and 1709230 were sampled and subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures. Based on the limited investigation, a cause for the reported issue could not be determined. Since the alleged defect cannot be confirmed, it has been determined no formal capa is required at this time.
 
Event Description
It was reported that the rubber stopper of the bd plastipak¿ concentric luer lock syringe was detached. It is unclear when the findings occurred. No reports of serious injury or medical intervention noted.
 
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Brand NameBD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
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
8015652845
MDR Report Key7630110
MDR Text Key112312162
Report Number3003152976-2018-00246
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBE
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
Type of Report Initial,Followup
Report Date 07/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
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: 06/22/2018 Patient Sequence Number: 1
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