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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH PRE-FILLED SYRINGE; SALINE VASCULAR ACCESS FLUSH

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BECTON DICKINSON, S.A. BD POSIFLUSH PRE-FILLED SYRINGE; 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 12/25/2023
Event Type  malfunction  
Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.
 
Event Description
It was reported that bd posiflush pre-filled syringe has no markings on the syringe.The following information was provided by the initial reporter, translated from chinese to english: the printing of the product is lost.
 
Manufacturer Narrative
A device history record review was completed for provided material number 306575 and lot number 3186664.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.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, a syringe was observed without the barrel label.Although the production history records did not show any issues, this defect most likely resulted from a failure in the vision system.The machinery has a vision system in place to detect issues with the barrel label, including missing label.If a syringe has no label, the rejection station must reject it; however, if there is a failure in this rejection, the station stops and the operator must identify the cause of stoppage and resolve the issue.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
BD POSIFLUSH PRE-FILLED 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
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18520348
MDR Text Key333506773
Report Number3002682307-2024-00001
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00382903065752
UDI-Public(01)00382903065752
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
UKN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/06/2024
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 Number306575
Device Lot Number3186664
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/26/2023
Initial Date FDA Received01/16/2024
Supplement Dates Manufacturer Received03/06/2024
Supplement Dates FDA Received03/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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