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U.S. Department of Health and Human Services

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

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BECTON DICKINSON SYRINGE 10ML SALINE FILL CE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
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.
 
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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 Key18809638
MDR Text Key337202730
Report Number1911916-2024-00153
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K161552
Number of Events Reported1
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 Number306575
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2024
Initial Date FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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