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 Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

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.

Event Description

It was reported 2 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% had foreign material.The following information was provided by the initial reporter: "patient reports black contamination on two posiflushes.".

Event Description

It was reported 2 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% had foreign material.The following information was provided by the initial reporter: "patient reports black contamination on two posiflushes.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 22-jun-2022.H6: investigation summary a device history record review was completed for provided material number 306572 and lot number 1343273.There was one possible incident recorded during the molding shift report for embedded burn marks; however, the affected product was held for inspection and any defective material found was scrapped.To aid in the investigation of this issue, picture samples and one physical sample were returned for evaluation by our quality engineer team.The syringe sample had been removed from the original blister packaging.Upon inspection of the sample, loose foreign matter was observed on the tip of the barrel.Fourier-transform infrared (ftir) spectroscopy was performed on the foreign material and the composition was found to be consistent with molybdenum sulphide lubricant.The ftir results indicate that the foreign material most likely resulted from the molding process.

• 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
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14292838
• MDR Text Key: 291289804
• Report Number: 9616657-2022-00013
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

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 Catalogue Number: 306572
• Device Lot Number: 1343273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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