MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 10ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 309110

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that an unspecified number of syringe s2 10ml leaked during use.The following was reported by the initial reporter: "two incidents: operating room: two luer cones broken (we still do not know the batch).Primary care: leakage of several syringes from the back (lot: 2007224).Further info received by bd representative on 1/25/2021.This original complaint pr has been split due to new update " leakage of several syringes from the back (lot: 2007224)".

Event Description

It was reported that an unspecified number of syringe s2 10ml leaked during use.The following was reported by the initial reporter: "two incidents: operating room: two luer cones broken (we still do not know the batch).Primary care: leakage of several syringes from the back (lot: 2007224).Further info received by bd representative on 1/25/2021.This original complaint pr has been split due to new update " leakage of several syringes from the back (lot: 2007224)".

Manufacturer Narrative

Investigation summary: a device history record review was completed for provided lot number 2007224.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As samples were unavailable for return, our quality team obtained twenty retained samples of the same lot number from the manufacturing facility for evaluation.Through examination of the retained samples, no defects were observed.Based on the investigation results, an exact manufacturing related cause could not be determined for this incident.Based on the provided customer feedback, it is possible that this incident resulted from damage to the plunger lip component.This type of damage can result from the handling of the product through the manufacturing process or during the assembly process.A quality procedure has been initiated with the aim of preventing this type of defect from recurring.The material used to manufacture the discardit syringes has been selected and tested to resist normal conditions of use.The assembly machines have an in-line camera system that inspects all product for signs of defect.Based on these preventive measures, it is possible that the mentioned syringe tip breakage was a consequence of strong conditions of use.

• Brand Name: SYRINGE S2 10ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 11344933
• MDR Text Key: 267966085
• Report Number: 3002682307-2021-00063
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

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: Health Professional
• Device Catalogue Number: 309110
• Device Lot Number: 2007224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1