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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 5ML LS; PISTON SYRINGE
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BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 5ML LS; PISTON SYRINGE Back to Search Results
Catalog Number 302130
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
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 when using the bd syringe 5ml ls, the device experienced discolored blister pack/ primary packaging.The following information was provided by the initial reporter.The customer stated: there is a foreign body in the package.
 
Manufacturer Narrative
H.6.Investigation: one photo was received by our quality team for evaluation.From the photos, foreign matter was observed inside the syringe packaging and products.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.As no samples were returned to determine the foreign matter type, the root cause could not be determined.
 
Event Description
It was reported when using the bd syringe 5ml ls, the device experienced discolored blister pack/ primary packaging.The following information was provided by the initial reporter.The customer stated: there is a foreign body in the package.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/8/2021.H.6.Investigation: one photo was received by our quality team for evaluation.From the photos, foreign matter was observed on the barrel flange.From the returned sample, brown foreign matter was observed on the barrel syringe.The brown foreign matter was sent for fourier transform infrared spectroscopy (ftir) analysis to determine the foreign matter type.The ftir results show that the spectrum of the foreign matter had no good match available in the library.The foreign matter showed some peaks that were similar to that of polypropylene, likely the base material of the syringe.This was likely because some of the base material was embedded in the foreign matter.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the device history record review, there is no heater change on the mold / press and no abnormality during the production run for the affected syringe batches.There were also no similar complaints received on embedded foreign matter associated with the syringe batches.Based on available information that only one piece of syringe is affected, the likely probable cause could have been attributed to contaminants in the resin where during the injection molding process the contaminants became embedded to the syringe barrel.
 
Event Description
It was reported when using the bd syringe 5ml ls, the device experienced discolored blister pack/ primary packaging.The following information was provided by the initial reporter.The customer stated: there is a foreign body in the package.
 
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Brand Name
BD SYRINGE 5ML LS
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12442088
MDR Text Key271332730
Report Number8041187-2021-00813
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302130
Device Lot Number1022175
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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