MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH SYRINGE 5ML SALINE FILL CE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

E street address provided: (b)(6).H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd posiflush syringe 5ml saline fill ce barrel was unlabeled.The following information was provided by the initial reporter: bd posiflush 5ml syringes that are prefilled with 0.9% sodium chloride to have no labelling on the actual syringe.There is no batch number on the packaging the syringes are individually wrapped in and unfortunately the box they came out of has been discarded.

• Brand Name: BD POSIFLUSH SYRINGE 5ML SALINE FILL CE
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18970350
• MDR Text Key: 338506398
• Report Number: 3002682307-2024-00060
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065745
• UDI-Public: (01)00382903065745
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306574
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1