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 Short Fill (1575)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced an incorrect fill, being less than the design specifications.The following information was provided by the initial reporter: there was no patient impact.The nurse removed a syringe from it¿s packet and it was sealed with cap intact but only had 2mls of saline in the syringe and the rest was air.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 2062724.The review revealed two non-conformance's during the production process that could potentially be related to reported incident.To aid in the investigation of this issue, two (2) picture samples were provided for evaluation by our quality engineer team.However, through examination of the pictures, we were unable to confirm the reported defect of incorrect fill.Based on the limited investigative sample results, we were unable to determine if the non-conformance identified during the production review contributed to the defect reported.H3 other text : see h10.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced an incorrect fill, being less than the design specifications.The following information was provided by the initial reporter: there was no patient impact.The nurse removed a syringe from it¿s packet and it was sealed with cap intact but only had 2mls of saline in the syringe and the rest was air.

• 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: 15850032
• MDR Text Key: 307694758
• Report Number: 9616657-2022-00043
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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: 2062724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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