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

Catalog Number 306575

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

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

Event Date 01/06/2021

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 10ml saline fill ce had difficult plunger movement during use.The following was reported by the initial reporter: "we had to deal with some 'difficult' syringes of posiflush today.When you use them, they suddenly become very stiff at 2 ml volume remaining in the syringe.It's as if the barrel narrows at that point, or there is less lubricant from that point on.(incidentally, the problem disappears if you move the pestle back and forth a few times, but by then the syringe is empty and unusable of course).".

Event Description

It was reported that an unspecified number of syringe 10ml saline fill ce had difficult plunger movement during use.The following was reported by the initial reporter: "we had to deal with some 'difficult' syringes of posiflush today.When you use them, they suddenly become very stiff at 2 ml volume remaining in the syringe.It's as if the barrel narrows at that point, or there is less lubricant from that point on.(incidentally, the problem disappears if you move the pestle back and forth a few times, but by then the syringe is empty and unusable of course).".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 5/5/2021.H6: investigation: a device history record review was completed for provided lot number 0230151.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, three syringes belonging to lot 0230151 were returned for evaluation by our quality engineer team.Two of the samples had a different tip cap on them (red).Each of the samples were found to have the stopper component stuck at different volumes, 6ml, 3ml, and 2ml, and they presented resistance to plunger movement.It has been determined that the sampling performed prior to lot release most likely failed to detect these faulty products.

• Brand Name: SYRINGE 10ML SALINE FILL CE
• 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: 11283897
• MDR Text Key: 230627072
• Report Number: 3002682307-2021-00034
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 306575
• Device Lot Number: 0203275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1