MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 20ML LL S/C 50; PISTON SYRINGE

Catalog Number 303310

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown device manufacture date: unknown investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.(b)(4).

Event Description

It was reported that an unspecified number of syringe 20ml ll s/c 50 have the packaging tear while opening leaving paper shards in the sterile field during use.The following was reported by the initial reporter: "it was reported that the paper backing does not peel open and contaminates the sterility of the syringe verbatim: i am reaching out to you because you are listed as the point of contact for bd luer-lok" 20ml syringes (manu: 303310) i have received multiple product concerns (see below) from (b)(6).***********, nurse manager  surgical services, and , ********* surgical tech, have reported that the paper backing of the 20ml syringes do not peel open correctly and it contaminates the sterility of the syringe.This has occurred with multiple lot numbers and they have returned the defective products to bd after speaking with their customer service team." have other facilities reported this type of concern with this packaging? " do you have a recommendation for * ************ moving forward as they are currently opening an average of 5-6 syringes until an acceptable sterile syringe is opened? paper backing does not peel open and contaminates the sterility of the syringe.When we open this syringe to the sterile field we need the paper backing to peel and not rip open.The 30ml syringe has a plastic backing and peel open allowing for sterile transition to the field.We often times will open 5 or 6 syringes in order to successfully open the package to the sterile field.".

• Brand Name: SYRINGE 20ML LL S/C 50
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11201697
• MDR Text Key: 227807911
• Report Number: 9614033-2021-00008
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 303310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• 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