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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL WWD; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL WWD; PISTON SYRINGE Back to Search Results
Catalog Number 301997
Device Problems Volume Accuracy Problem (1675); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8315842.Medical device expiration date: 2023-10-31.Device manufacture date: 2018-11-11.Medical device lot #: 8315843.Medical device expiration date: 2023-11-30.Device manufacture date: 2018-11-11.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 before use of the bd syringe 10ml ll wwd the syringes were deformed.Three syringes had this condition.The following information was provided by the initial reporter, translated from (b)(6) to english: the 3 products were deformed.
 
Manufacturer Narrative
H.6.Investigation: six photos and three loose 10ml syringes were received and evaluated.It was observed in the photos and physical samples the barrels and plunger rods contained significant damage including portions of the flanges and plunger rods broken off as well as large cracks and deformations on the barrels.The damage was rejectable per product specification.Potential root cause for the damage is associated with the assembly process.This may have been caused by a self- correcting dial jam due to the small number reported and undetected.The severity of the damage and the fully assembled syringes indicates it was a large amount of force very quickly which would most likely occur at the dials.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number that could have contributed to the reported defect.
 
Event Description
It was reported that before use of the bd syringe 10ml ll wwd the syringes were deformed.Three syringes had this condition.The following information was provided by the initial reporter, translated from japanese to english: the 3 products were deformed.
 
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Brand Name
BD SYRINGE 10ML LL WWD
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9135161
MDR Text Key194530251
Report Number1213809-2019-00983
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903028307
UDI-Public30382903028307
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301997
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2019
Date Manufacturer Received09/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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