MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE FILL CE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Missing Information (4053)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

We have encountered a fault on the 5 x posiflush 10ml saline syringes in dunedin icu: no markings on the syringes.Please see attached fault form and pics.Susan has the syringes in icu dunedin if you want them returned: please advise.We don¿t have the batch number.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

To aid in the investigation of this issue, one (1) picture sample and three (3) physical samples were returned for evaluation by our quality team.Through examination of the samples, three (3) syringes were identified without the barrel labels.As the lot is unknown for this incident, a review of the production history records could not be performed.The material involved (10ml syringe) could be manufactured in six (6) validated lines.No quality notifications or second samplings have been reported from october 2021 to present that could have contributed to this defect.All of the plunger assembly and labelers have a vision system to detect any issues that may occur.If a syringe has no label, the rejection system must reject the syringe.If there is a failure in this rejection process, the station stops and the operator must resolve the issue.It is most likely that this incident resulted from an error in the double rejection station.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: SYRINGE 10ML SALINE FILL CE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18809638
• MDR Text Key: 337202730
• Report Number: 1911916-2024-00153
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

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: Health Professional
• Device Catalogue Number: 306575
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1