MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problems Short Fill (1575); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2020

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 there was only "4ml" of nacl 0.9% found in the bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.Additionally, it was reported that foreign particles resembling "salt crystallization" were found in the syringe.The defects were found prior to use.The following information was provided by the initial reporter: "nurse reports opening the syringe and there only being 4ml in the syringe, also reports particles, querying salt crystallization.".

Event Description

It was reported that there was only "4ml" of nacl 0.9% found in the bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.Additionally, it was reported that foreign particles resembling "salt crystallization" were found in the syringe.The defects were found prior to use.The following information was provided by the initial reporter: "nurse reports opening the syringe and there only being 4ml in the syringe, also reports particles, querying salt crystallization".

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 2020-07-16 h.6.Investigation summary to aid in the investigation of this issue, both pictures and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, the reported defects of incorrect fill and foreign particles were identified.It has been concluded that there was an intermittent issue with the tip cap torque heads during the production process, which was resolved at the time of the issue.All product associated with this production defect was held for inspection and any affected material should have been scrapped.It is possible that this issue may have occurred prior to the detection and that a limited occurrence of material was not contained.Due to the tip cap issue, the saline most likely leaked from the loose tip cap component and evaporated in the blister packaging, causing the salt particles to remain.Our quality team will closely monitor the production process for any potential signs of this defect or emerging trends.See h.10.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10105590
• MDR Text Key: 195706619
• Report Number: 9616657-2020-00084
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9351570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other