MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 3 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE

Catalog Number 306573

Device Problem Leak/Splash (1354)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the 3 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% experienced stopper separation from the plunger.The following information was provided by the initial reporter: the seal disconnected from the plunger.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/18/2021.H.6.Investigation: a device history record review was completed for provided lot number 0037871.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, one syringe sample was returned for evaluation by our quality engineer team.The syringe was received with a plunger disconnected from the barrel and the plunger rod tip was damaged.The sample was not used as all of the saline solution remained within it.An additional sixty retained samples of the same lot number were obtained from the manufacturing facility for further evaluation.The retained samples were inspected and no signs of plunger disconnection were found.Due to the plunger rod damage, it is most likely that this defect resulted during the plunger assembly process.In this step of the manufacturing process, the plunger is assembled into the stopper by use of pressure.If the assembly machine is not adjusted properly, the plunger rod may become damaged and could become loose from the barrel after the manufacturing vision inspection is performed.

Event Description

It was reported that the 3 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% experienced stopper separation from the plunger.The following information was provided by the initial reporter: the seal disconnected from the plunger.

• Brand Name: 3 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 11341463
• MDR Text Key: 232336760
• Report Number: 3002682307-2021-00060
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 306573
• Device Lot Number: 0037871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1