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

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.

• Brand Name: SYRINGE 1ML S/T U100 25G 1IN
• Type of Device: SYRINGE
• 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 Key: 11979933
• MDR Text Key: 267351852
• Report Number: 1213809-2021-00419
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 329622
• Device Lot Number: 1057671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1