MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 5ML 22GA 1-1/4IN

Catalog Number 301942

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Pain (1994)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as a lot number was unavailable for return, a review of the production history records could not be performed for this incident.As samples were not returned, a thorough sample analysis was also unable to be performed.Based on the provided feedback, it is possible that this incident resulted from damage to the plunger lip component, causing leakage.This type of plunger damage can occur during the handling of the product through manufacturing process or within the plunger assembly machine.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.A quality process was initiated with the aim of reducing this type of defect.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.Investigation conclusion: based on the customer feedback of the issue, we conclude that the cause of the problem could be produced as a consequence of a damage in the plunger lip, that damage caused the reported leak issue.This damage could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.

Event Description

It was reported that the syringe s2 5ml 22ga 1-1/4in experienced air bubbles during blood draw.The following information was provided by the initial reporter: on (b)(6) 2021, when a nurse used a 5 ml syringe to collect blood samples from a child, the syringe was drawing air instead of blood.The connection with the infusion needle was tightened, but air was still drawn.The position of the infusion needle remained unchanged, and another 5 ml syringe was replaced to draw out the blood successfully.

• Brand Name: SYRINGE S2 5ML 22GA 1-1/4IN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12254850
• MDR Text Key: 266008596
• Report Number: 3002682307-2021-00369
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301942
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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