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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿¿ ORAL SYRINGE WITH TIP CAP
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BECTON DICKINSON MEDICAL SYSTEMS BD¿¿ ORAL SYRINGE WITH TIP CAP Back to Search Results
Catalog Number 305210
Device Problems Unsealed Device Packaging (1444); Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a, this is a pharmacy medication dispenser 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 with the use of the bd¿ oral syringe with tip cap there was an issue with sterility breach.It was stated the consumer ¿observed some contamination within the bags and one bag was only partially sealed resulting in syringes falling out.One bag contains a piece of wood and another bag contains cardboard.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 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 with the use of the bd oral syringe with tip cap there was an issue with sterility breach.It was stated the consumer ¿observed some contamination within the bags and one bag was only partially sealed resulting in syringes falling out.One bag contains a piece of wood and another bag contains cardboard.¿ there was no report of injury or further medical intervention.
 
Event Description
It was reported with the use of the bd¿ oral syringe with tip cap there was an issue with sterility breach.It was stated the consumer ¿observed some contamination within the bags and one bag was only partially sealed resulting in syringes falling out.One bag contains a piece of wood and another bag contains cardboard.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: sample evaluation: four sealed bags of 3ml oral amber syringes with tip caps were received and confirmed to be from batch #8092683 (b)(4).The samples were visually evaluated.Bag 1 piece of wood observed in bag.The fm was larger than level 3 in size which is a rejectable condition per product specification.Bag 2 a 1 inch opening at bottom seal was found which is a rejectable condition.Bag 3 a piece of cardboard larger than level 3 in size observed in bag.Fm this size is rejectable.Bag 4 -black fm which appears to be grease greater than level 3 in size observed on the plunger rod thumb rest.Fm this size is rejectable at bd canaan.Dhr review for batch 8092683 (b)(4).Manufacturing dates: 04/12/2018 to 04/13/2018.Batch quantity was 246,000.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8092683 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: based on the evaluation performed the defects, as noted by the end user, can be verified.Root cause was not determined.
 
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Brand Name
BD¿¿ ORAL SYRINGE WITH TIP CAP
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7637695
MDR Text Key112452816
Report Number1213809-2018-00378
Device Sequence Number1
Product Code KYW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305210
Device Lot Number8092683
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2018
Date Manufacturer Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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