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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE Back to Search Results
Catalog Number 309628
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that foreign matter (described as ¿greasy substance¿) was found on the plunger of a 1 ml bd luer-lok¿ disposable syringe.There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.
 
Event Description
It was reported that foreign matter (described as ¿greasy substance¿) was found on the plunger of a 1 ml bd luer-lok¿ disposable syringe.There was no report of exposure, injury or medical intervention.
 
Event Description
It was reported that foreign matter (described as ¿greasy substance¿) was found on the plunger of a 1 ml bd luer-lok¿ disposable syringe.There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: four photos depicting a syringe with an off white oval on the barrel wall near the barrel collar.All four photos appear to be of the same syringe.The white oval appears larger than level three in size, which is rejectable per product specification.Based on the photo evaluation the foreign matter is unidentified.Additionally, eight sealed 1ml packaged syringes were received and confirmed to be from batch #7300833 (b)(4).The samples were visually evaluated.No defects were identified during evaluation, therefore defects not confirmed.Moreover, the complaint is for ¿operator felt oil touching the plunger¿ which sounds like a silicone issue.The photos appear to be white foreign matter on the barrel wall and the physical samples are sealed packaged syringes without defects observed.The physical samples and photos were different samples and did not match defect as described in complaint details.Furthermore, 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.This is the 1st related complaint for fm on the provided lot number 7300833 occurrence is 1.The severity level is s1.The investigation level is b.Release date: 11/08/2017.Released quantity was 302,400.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7300833 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The reported defect was not identified in the physical samples received.The root cause is not defined since defects were not confirmed in samples received.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7673105
MDR Text Key113536715
Report Number1213809-2018-00403
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096283
UDI-Public30382903096283
Combination Product (y/n)N
PMA/PMN Number
K980987
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 08/14/2018
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 Expiration Date09/30/2022
Device Catalogue Number309628
Device Lot Number7300833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Initial Date Manufacturer Received 06/18/2018
Initial Date FDA Received07/10/2018
Supplement Dates Manufacturer Received06/18/2018
06/18/2018
Supplement Dates FDA Received08/08/2018
09/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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