MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Volume Accuracy Problem (1675)

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

Event Date 01/21/2022

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 while using bd¿ posiflush¿ saline xs 10 ml the scale marking was missing on two syringes.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: product: bd posiflush xs 10 ml lot number: 1203643 product expiry date: 30-jun-2024 number of defective product(s): 2 is sample available: yes unable to verify that the fluid in the syringe matches the description on the package.Syringe was lacking all appropriate markings and labelling.

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml the scale marking was missing on two syringes.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: product: bd posiflush xs 10 ml.Lot number: 1203643.Product expiry date: 30-jun-2024.Number of defective product(s): 2.Is sample available: yes.Unable to verify that the fluid in the syringe matches the description on the package.Syringe was lacking all appropriate markings and labelling.

Manufacturer Narrative

H6: investigation: a device history record review was completed for provided material number 306572 and lot number 1203643.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.As samples were not returned for this incident, a thorough sample analysis could not be completed by our quality engineer team.Based on the limited investigation results, an exact cause related to the manufacturing process could not be determined for this issue.

• Brand Name: BD¿ POSIFLUSH¿ SALINE XS 10 ML
• 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: 13473157
• MDR Text Key: 286151949
• Report Number: 9616657-2022-00003
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• 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: 02/09/2022

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: 1203643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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