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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD DISCARDIT II SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 309210
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979)
Patient Problem No Patient Involvement (2645)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0133764, medical device expiration date: 2025-04-30, device manufacture date: 2020-05-12, medical device lot #: 0072008, medical device expiration date: 2025-02-28, device manufacture date: 2020-03-12.Medical device lot #: 0209304, medical device expiration date: 2025-06-30, device manufacture date: 2020-07-27.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that an unspecified number of bd discardit¿ ii syringes from lots 0133764, 0072008, and 0209304 had issues with foreign fibers and defective plungers found in them before use.The following information was provided by the initial reporter: 'at the final inspection (product release) our qc found white swarfs / fibres inside the 20 ml syringe's barrel.According to the color the swarfs / fibres might come from the plunger.Our qc also observed a bad moulding of the plunger.The length of the found swarfs / fibres reach from the 2-3 mm up to 2.5 cm and are located inside the barrel.So they can easily flushed inside the blood vessel system with serious health hazard for the patients.Random sampling of our stock shows that all batches (0133764, 0072008) of the 20 ml syringe are affected.No products have been brought to our customer's yet, which avoids a market recall.".
 
Event Description
It was reported that an unspecified number of bd discardit¿ ii syringes from lots 0133764, 0072008, and 0209304 had issues with foreign fibers and defective plungers found in them before use.The following information was provided by the initial reporter: 'at the final inspection (product release) our qc found white swarfs / fibres inside the 20 ml syringe's barrel.According to the color the swarfs / fibres might come from the plunger.Our qc also observed a bad moulding of the plunger.The length of the found swarfs / fibres reach from the 2-3 mm up to 2.5 cm and are located inside the barrel.So they can easily flushed inside the blood vessel system with serious health hazard for the patients.Random sampling of our stock shows that all batches (0133764, 0072008) of the 20 ml syringe are affected.No products have been brought to our customer's yet, which avoids a market recall.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/14/2020.H.6.Investigation: a device history record review was performed for provided lot numbers 0133764, 0072008, and 0209304.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, white particles were observed within the syringe.After analyzing the returned sample and discussing this issue with our manufacturing technicians, it has been concluded that the particles observed within the syringe are composed of lubricant from the syringe barrel.During the manufacturing process, the lubricant forms a microscopic layer in the internal and external walls of the syringe barrel.When the plunger is moved backwards during the filling of the syringe, most of this microscopic layer of lubricant is dragged behind the plunger and a small quantity still remains inside of the syringe to allow for a good sliding performance during the injection process.This lubricant is a normal process and critical for proper function of the product.The lubricant used within the syringe is below all regulated maximum limits and a toxicological material risk assessment for the slip agent indicates an extremely low to negligible risk of this material during clinical application.H3 other text : see h.10.
 
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Brand Name
BD DISCARDIT II SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
MDR Report Key10709336
MDR Text Key214395798
Report Number3002682307-2020-00318
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
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 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309210
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Date Manufacturer Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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