MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

Catalog Number 300865

Device Problems Inappropriate Audible Prompt/Feedback (2280); Defective Component (2292)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

It was reported that 5 bd plastipak¿ 50ml concentric luer lock syringes experienced difficult plunger movement, and syringe pump alarm during syringe use.The following information was provided by the initial reporter: i hereby report that during the use of the bd plastipak luer-lok 60 ml syringes difficulties in use were encountered due to the excessive resistance of the plunger during its retraction for aspiration of drugs.The difficulty of use is that, as a result of what was previously stated, the same syringes, set on syringe pumps, caused the pumps to alarm.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter phone #: (b)(6).Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 5 bd plastipak¿ 50ml concentric luer lock syringes experienced difficult plunger movement, and syringe pump alarm during syringe use.The following information was provided by the initial reporter: i hereby report that during the use of the bd plastipak luer-lok 60 ml syringes difficulties in use were encountered due to the excessive resistance of the plunger during its retraction for aspiration of drugs.The difficulty of use is that, as a result of what was previously stated, the same syringes, set on syringe pumps, caused the pumps to alarm.

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h.10.

• Brand Name: BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
• 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: 12794914
• MDR Text Key: 284989233
• Report Number: 3002682307-2021-00607
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• 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