MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ANESTHESIA SYRINGE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number UNKNOWN

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Unknown manufacturer: (b)(4).

Event Description

It was reported that an unspecified bd anaesthesia needle had a difficult to move plunger.The following information was provided by the initial reporter: "material no: unknown batch no: unknown.It was reported that the customer just had a patient tell me they are lasting maybe a day and ½ before they have to throw them out.Verbatim: i do not have any specific lot numbers, or syringes in my possession other than new in the package, or for that matter any particular patient name.We have had many complaints over the past few years about these syringes.One patient even went to the extent of trimming down the black rubber on the plunger to get it to move freely.I just had a patient tell me they are lasting maybe a day and ½ before they have to throw them out.".

• Brand Name: UNSPECIFIED BD ANESTHESIA SYRINGE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10841536
• MDR Text Key: 216409766
• Report Number: 2243072-2020-01831
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/15/2020
• 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