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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LL
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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LL Back to Search Results
Catalog Number 302149
Device Problems Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 10ml ll molding was defective and had extraneous plastic on the tip of the syringe.This was discovered before ues.The following information was provided by the initial reporter: extraneous plastic on tip of ll syringe.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/19/2020.H.6.Investigation: two photos and six actual samples were received by our quality team for evaluation.Upon visual inspection of the photos and samples, it was observed that there were flashes on the barrel tip; therefore, the incident could be verified.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 investigation, the measurements of the flashes were within specification.The actual sample passed the flashes acceptance criteria as per drawing specification.No abnormality was observed during the production run.A review of past 12 months quality notification was performed.No similar quality notification was raised for the reported defect.Therefore, the root cause cannot be determined.
 
Event Description
It was reported that syringe 10ml ll molding was defective and had extraneous plastic on the tip of the syringe.This was discovered before ues.The following information was provided by the initial reporter: extraneous plastic on tip of ll syringe.
 
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Brand Name
SYRINGE 10ML LL
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key10094006
MDR Text Key195577129
Report Number8041187-2020-00287
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 distributor,foreign,other
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302149
Device Lot Number9353742
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Initial Date Manufacturer Received 05/07/2020
Initial Date FDA Received05/27/2020
Supplement Dates Manufacturer Received05/07/2020
Supplement Dates FDA Received07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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