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

Catalog Number 301942

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).Investigation summary: a device history record review was completed for provided lot number 2007152.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples of the same lot number were obtained from the manufacturing facility for further evaluation.The retained samples were examined and no signs of defect were identified.It is possible that this incident resulted from damage to the plunger lip component.This type of damage may be produced during the handling of the product through the manufacturing facility or during the assembly process.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.Further action has not been determined necessary at this time.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

It was reported that syringe s2 5ml 22ga 1-1/4in bd (b)(4) leaked.The following information was provided by the initial reporter: "before intravenous blood sampling, check the syringe for air leakage and cannot be used normally.".

• Brand Name: SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA
• Type of Device: PISTON 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: 12242887
• MDR Text Key: 266009922
• Report Number: 3002682307-2021-00362
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301942
• Device Lot Number: 2007152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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