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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE Back to Search Results
Catalog Number 301229
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: unknown. Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported with the use of the bd plastipak¿ 30ml luer-lock syringe there was an issue with stopper separation from plunger. It was stated by the consumer ¿the rubber on the plunger has slipped. It is on the side. ¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: one sample unit and two pictures were received for evaluation by our quality engineer. Upon visual inspection of the samples, the stopper was observed misassembled within the syringe and it was distorted against the barrel walls. No damages or molding defects were observed to the plunger rod or to the stopper that could have caused this defect. As a lot number is unknown for this incident, a production history review could not be performed. Within the assembly station of the manufacturing line, there is a photo-cell which detects wrongly assembled stoppers and syringes without stoppers. The disassembled stopper is a result of a misalignment of the plunger, stopper, and barrel in the assembly station. A project has been opened to reduce the occurrence of this defect. Improvements will include mechanical changes in the assembly station and a new vision system to detect the defective product.
 
Event Description
It was reported with the use of the bd plastipak¿ 30ml luer-lock syringe there was an issue with stopper separation from plunger. It was stated by the consumer ¿the rubber on the plunger has slipped. It is on the side. ¿ there was no report of injury or further medical intervention.
 
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Brand NameBD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key7681320
MDR Text Key114032577
Report Number3003152976-2018-00277
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,Followup
Report Date 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301229
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/12/2018 Patient Sequence Number: 1
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