MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the unspecified bd¿ syringe plunger was difficult to move when trying to withdraw insulin.The following information was provided by the initial reporter: "caller reported that the syringe was not moving when trying to putting in insulin".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12703547
• MDR Text Key: 278545771
• Report Number: 2243072-2021-02598
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• 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
• Patient Age: 29 YR