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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML TB SYRINGE SLIP TIP; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD 1ML TB SYRINGE SLIP TIP; PISTON SYRINGE Back to Search Results
Catalog Number 309623
Device Problems Leak/Splash (1354); Difficult to Remove (1528); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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 that a bd 1ml tb syringe slip tip had leakage.The following was reported, "consumer reported needle hub separated when pulling off shield.Also mentioned, when she re-attached the hub on one syringe, the medication leaked out.Stated shields are hard to remove.5 syringes affected.Occurrence dates unknown.Lot: unknown, item: 309623, no expiration date.Samples available.Per consumers request, sending item: 328411 as replacement.".
 
Manufacturer Narrative
Investigation: sixteen 1ml syringes with needles (p/n 309623) were received and visually inspected.Thirteen were in fully sealed blister packs with twelve confirmed to be from batch #4119922 and one confirmed to be from batch #8213898.Three were in opened blister from batch #8213898.One of the shields from a syringe in an opened blister pack was observed to have small cracks where the hub contacts the shield.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.A shield removal force test was performed on all unopened samples using a force gage.No defects were observed.Root cause not defined since defects were not confirmed in the samples received.
 
Event Description
It was reported that a bd 1ml tb syringe slip tip had leakage.The following was reported, "consumer reported needle hub separated when pulling off shield.Also mentioned, when she re-attached the hub on one syringe, the medication leaked out.Stated shields are hard to remove.5 syringes affected.Occurrence dates unknown.Lot: unknown, item: 309623, no expiration date.Samples available.Per consumers request, sending item: 328411 as replacement.".
 
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Brand Name
BD 1ML TB SYRINGE SLIP TIP
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8426168
MDR Text Key139186010
Report Number1213809-2019-00345
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096238
UDI-Public30382903096238
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309623
Device Lot NumberUNKNOWN
Date Manufacturer Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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