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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ENTERAL 10ML BNS; ENTRAL SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ENTERAL 10ML BNS; ENTRAL SYRINGE Back to Search Results
Catalog Number 305858
Device Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8283661; medical device expiration date: 2023-09-30; device manufacture date: 2018-10-10; medical device lot #: 7249730; medical device expiration date: 2022-08-31; device manufacture date: 2017-09-06; medical device lot #: 7312795; medical device expiration date: 2022-10-31; device manufacture date: 2017-11-08; medical device lot #: 8108771; medical device expiration date: 2023-03-31; device manufacture date: 2018-04-18; medical device lot #: 8120914; medical device expiration date: 2023-04-30; device manufacture date: 2018-04-30.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 before use of the syringe enteral 10ml bns the syringe is blocked due to a foreign object.Material no.: 305858, batch no.: unknown.The following information was provided by the initial reporter: per email: please be advised that we have received the above noted complaint concerning the 10ml for oral/enteral use only syringe component where the customer advised that the tip of the syringe was found to be completely blocked.
 
Manufacturer Narrative
Investigation summary: two photos and one loose 10ml oral syringe was received and evaluated.It was observed there was a small orange piece of foreign matter in the fluid path wedged in the tip of the syringe.It appears to be a piece of plastic from a tip cap.Ftir (fourier transform infrared ) spectroscopy analysis was completed on the orange material observed in the tip of the syringe and was compared with the ftir analysis of the loose orange tip cap received along with the syringe.A small portion of each of these material was removed and prepared for ftir spectral analysis.The spectral analysis shows that the material in the tip of the syringe is most likely polypropylene while the material of the tip cap is most likely polyethylene.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Tip caps are not manufactured or packaged with this product.No corrective actions recommended since product defect was not confirmed.
 
Event Description
It was reported that before use of the syringe enteral 10ml bns the syringe is blocked due to a foreign object.Material no.: 305858 batch no.: unknown.The following information was provided by the initial reporter: per email: please be advised that we have received the above noted complaint concerning the 10ml for oral/enteral use only syringe component where the customer advised that the tip of the syringe was found to be completely blocked.
 
Event Description
It was reported that before use of the syringe enteral 10ml bns the syringe is blocked due to a foreign object.Material no.: 305858 batch no.: unknown.The following information was provided by the initial reporter: per email: please be advised that we have received the above noted complaint concerning the 10ml for oral/enteral use only syringe component where the customer advised that the tip of the syringe was found to be completely blocked.
 
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Brand Name
SYRINGE ENTERAL 10ML BNS
Type of Device
ENTRAL SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8569314
MDR Text Key144976545
Report Number1213809-2019-00492
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903058587
UDI-Public382903058587
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 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305858
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Initial Date Manufacturer Received 04/11/2019
Initial Date FDA Received05/01/2019
Supplement Dates Manufacturer Received04/11/2019
Supplement Dates FDA Received06/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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