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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE CONTROL 10ML LL BNS; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE CONTROL 10ML LL BNS; PISTON SYRINGE Back to Search Results
Catalog Number 304134
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8323971.Medical device expiration date: na.Device manufacture date: 11-19- 2018.Medical device lot #: 8323972.Medical device expiration date: na.Device manufacture date: 11-19- 2018.
 
Event Description
It was reported that an unspecified number of syringe control 10ml ll bns experienced a molding defect with sharp protrusions which was noted prior to use.The following information was provided by the initial reporter: material no.: 304134 batch no.: 8323971, 8323972.Verbatim: the failure rate is 67.3% across 400ea (200ea from two different lots).
 
Event Description
It was reported that an unspecified number of syringe control 10ml ll bns experienced a molding defect with sharp protrusions which was noted prior to use.The following information was provided by the initial reporter: material no.: 304134.Batch no.: 8323971, 8323972.Verbatim: (b)(4).
 
Manufacturer Narrative
H.6.Investigation summary: two photos were received and evaluated.The photos depict finger grips and thumb grip of two 10ml control syringes from unidentified batches.Deformations in the white plastic where it comes in contact with the clear plastic of the barrels were observed.The deformations have the appearance of melting or flash and are located near the weld points.Dhr review for batch #8270914: release date: 10/22/2018.Released quantity was (b)(4).All visual inspections were performed as per requirement.A quality notification was issued for weld issues during the manufacture of this batch.Production was stopped, adjustments were made and product requalified per applicable aql before production resumed.Batch 8270914 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch #8323971: release date: 12/12/2018.Released quantity was (b)(4).All visual inspections were performed as per requirement.Welding issues were recorded during the manufacture of this batch.Production was stopped, adjustments were made and product requalified per applicable aql before production resumed.Batch 8323971 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Physical sample is required to better evaluate the observed defect.Dhr review for batch #8323972: release date: 12/12/2018.Released quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8323972 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Potential root cause for the flash observed is likely a result of a temporary issue with the welding process.However, a physical sample is required for evaluation and to confirm potential root cause determination.Corrections took place at the time the defects were found in production, including machine adjustments and product requalification per aql.It is possible a limited number of pieces with the observed defect escaped detection.The aql for plastic protruding from the weld area is 1.0%.Defective rate identified is 2 out of batch size 144,000, which is 0.0014%.No additional actions are necessary at this time.Batches 8270914 and 8323971 are considered in compliance with our product specification requirements.Controls are in place which include periodic visual product inspections to ensure containment of defects and overall product quality.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.H3 other text : see section h.10.
 
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Brand Name
SYRINGE CONTROL 10ML LL BNS
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9285890
MDR Text Key197134388
Report Number1213809-2019-01115
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 02/24/2020
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 Number304134
Device Lot NumberSEE H.10
Initial Date Manufacturer Received 10/22/2019
Initial Date FDA Received11/06/2019
Supplement Dates Manufacturer Received10/22/2019
Supplement Dates FDA Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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