MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 10ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306565

Device Problem Problem with Sterilization (1596)

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

Event Date 11/28/2022

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 that 2 10ml bd posiflush¿ sterile field (sf) saline syringes experienced damaged packaging where sterility was compromised.The following information was provided by the initial reporter: filled syringes have come with package torn.

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided material number 306565 and lot number 2068415.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 neither picture samples nor physical samples were available, a thorough sample analysis could not be performed.

Event Description

It was reported that 2 10ml bd posiflush¿ sterile field (sf) saline syringes experienced damaged packaging where sterility was compromised.The following information was provided by the initial reporter: filled syringes have come with package torn.

• Brand Name: 10ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16080779
• MDR Text Key: 308474667
• Report Number: 3002682307-2022-00356
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306565
• Device Lot Number: 2068415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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