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.

Manufacturer Narrative

To aid in the investigation of this issue, a picture sample and the affected physical sample were returned for evaluation by our quality team.Through examination of the sample, a syringe was observed missing the barrel label.As the batch number for this syringe could not be identified, a standard production history review could not be performed.The 5ml 306574 syringe is manufactured on line 2.No quality notifications or second samples were identified on this line from october 2021 to present that could have contributed to this defect.Although the exact cause could not be determined, it is possible this incident resulted from an error in the vision system, specifically at the double rejection station.If a syringe has no label, the vision system must identify it and reject the syringe.If there is a failure in the rejection process, the machine automatically stops and the operator must resolve the issue manually.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• 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

• 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
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1