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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T U100 25G 1IN

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T U100 25G 1IN Back to Search Results
Catalog Number 329622
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. The customer's address is unknown:  (b)(6) has been used as a default.   investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. This is the 1st related complaint for the reported lot number. A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Investigation conclusion: a complaint history check was performed and this is the 1st related complaint for volumetric accuracy on lot # 1057671. Release date: 4/01/2021. Released quantity was 698,400. All visual inspections were performed as per requirement with no quality notifications related to the complaint defect. Batch 1057671 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment. As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Based on the above, no additional investigation and no capa/sa is required at this time.
 
Event Description
It was reported that the syringe 1ml s/t u100 25g 1in experienced issues with the syringe volumetric accuracy. The following information was provided by the initial reporter: material no: 329622. Batch no: 1057671. Since there is a shortage of supplied needles and syringes with the covid-19 vaccines, our company has been using bd 1ml insulin syringe u-100 25g x 1 inch to administer the pfizer-biontech vaccine recently. After following the manufacturer's instruction of adding 1. 8ml 0. 9% nacl sterile diluent into the vaccine vial, i was not able to withdraw the 6 full 0. 3ml doses from one vial, using the needle/syringe mentioned above. I was short of 0. 05ml with the last dose. There was no spillage or wastage. We used the other kind of needle/syringe type before without issues, and was able to get 7 x 0. 3ml doses from one vial sometimes. After comparing the above mentioned needle/syringe with others physically, i noticed the hub connecting the needle and syringe is bigger than others. It may take up more dead spaces (wasted volume). It may not be a big issue when using a bigger multi-dose vial. However, when using a small vial like the pfizer-biontech vaccine, it will not be able to withdraw the intended minimum of 6 doses.
 
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Brand NameSYRINGE 1ML S/T U100 25G 1IN
Type of DeviceSYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11979933
MDR Text Key267351852
Report Number1213809-2021-00419
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number329622
Device Lot Number1057671
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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