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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305822
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd¿ luer tip cap bulk tray of 50, natural color, sterile the product was received expired.The following information was provided by the initial reporter: material no: 305822 batch no: 5111785.It was reported missing expiration date verbatim: customer received product that had a manufacture date of 2015 and questioned whether it was usable it was determined that the shelf life was 5 years, so this product is expired and not usable we received 305822, lot no.5111785 with a manufacturing date of 2015/05/28 and no expiry date.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd¿ luer tip cap bulk tray of 50, natural color, sterile the product was received expired.The following information was provided by the initial reporter: material no: 305822 batch no: 5111785.It was reported missing expiration date verbatim: customer received product that had a manufacture date of 2015 and questioned whether it was usable it was determined that the shelf life was 5 years, so this product is expired and not usable we received 305822, lot no.5111785 with a manufacturing date of 2015/05/28 and no expiry date.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11-feb-2022.H.6.Investigation: it was reported that the expiration date is missing.The reported issue is confirmed.However, at the time of manufacturing of this batch an expiration date was not required on the product packaging.Bd has since that time implemented a process for assigning expiration date to the packaging.H3 other text : see h.10.
 
Event Description
It was reported while using bd¿ luer tip cap bulk tray of 50, natural color, sterile the product was received expired.The following information was provided by the initial reporter: material no: 305822.Batch no: 5111785.It was reported missing expiration date.Verbatim: customer received product that had a manufacture date of 2015 and questioned whether it was usable it was determined that the shelf life was 5 years, so this product is expired and not usable we received 305822, lot no.5111785 with a manufacturing date of 2015/05/28 and no expiry date.
 
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Brand Name
BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13404515
MDR Text Key285421583
Report Number1213809-2022-00030
Device Sequence Number1
Product Code KYW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/27/2020
Device Catalogue Number305822
Device Lot Number5111785
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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