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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 Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2018
Event Type  malfunction  
Manufacturer Narrative
(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 with the use of the bd plastipak¿ concentric luer lock syringe there was an issue with air bubbles from pierced plastipak. There was no report of injury or medical intervention.
 
Event Description
It was reported with the use of the bd plastipak concentric luer lock syringe there was an issue with air bubbles from pierced plastipak. There was no report of injury or medical intervention.
 
Manufacturer Narrative
One physical sample and one picture sample were received for evaluation. Upon visual inspection of the samples, a molding defect was observed on the barrel of the syringe at the edge of the tip case. A device history record review did not reveal any documented quality issues during the production of lot number 1806247 that could have contributed to the reported/observed defect. The observed defect was a result of a partial obstruction in the injection point of the mold when the injection machine was re-started. Before the machine is re-started, it is purged until the material is acceptable and the first pieces are rejected per procedure. The product in question was an undetected defect during this process. Based on the preventive measures in place and our current inspection plan, we believe this is an isolated incident with an unlikely recurrence. The observed defect was a result of a partial obstruction in the injection point of the mold when the injection machine was re-started.
 
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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
MDR Report Key7891192
MDR Text Key120970133
Report Number3003152976-2018-00403
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number1806247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/19/2018 Patient Sequence Number: 1
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