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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ HEPARIN LOCK FLUSH SYRINGE; PISTON SYRINGE

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BECTON DICKINSON UNSPECIFIED BD¿ HEPARIN LOCK FLUSH SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Missing Information (4053)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2023
Event Type  malfunction  
Event Description
It was reported that the unspecified bd¿ heparin lock flush syringe had no drug information label on it.The following information was provided by the initial reporter: "i would like to report a bd heparin lock flush 10u/ml 3ml syringe that was found with no drug information label".
 
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported a bd heparin lock flush was found without the label.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe in its packaging flow wrap that is missing the syringe barrel label.No other defects or imperfections were observed.This defect could occur if there was a jam during the labeling process.As the material and lot number provided are 'unknown,' a device history record review could not be completed.Verification of the labeling process was performed.The settings were correct, and the flow of product was good.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.
 
Event Description
No additional information received mat#: unknown lot#: unknown.It was reported by customer that bd heparin lock flush 10u/ml 3ml syringe that was found with no drug information label (pictured below).Verbatim: complaint received via email.Email(s) attached.Question i would like to report a bd heparin lock flush 10u/ml 3ml syringe that was found with no drug informationlabel (pictured below).Unfortunately, we do not have the lot of the syringe or the original box it came in sinceit was found in the pyxis machine.We checked all syringes in stock and did not find any more with missinglabels.Please advise on next steps or if you have any questions.
 
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Brand Name
UNSPECIFIED BD¿ HEPARIN LOCK FLUSH SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17837267
MDR Text Key324936634
Report Number2243072-2023-01739
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2023
Initial Date FDA Received09/28/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Yes
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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