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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE; SALINE, VASCULAR ACCESS FLUSH

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306546
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd posiflush¿ iv flush solution sodium chloride had a deformed tip cap.The following information was provided by the initial reporter: the customer complained that the white tip cap was found deformed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/17/2021.H.6.Investigation: it was reported the white tip cap was found deformed.To aid in the investigation, one sample in a sealed packaging flow wrap and two photos were provided for evaluation by our quality team.A visual inspection was performed and the tip cap is damaged.No other defects or imperfections were observed.This defect could occur if when loading the syringe in the sterilization tray it was misplaced and damaged when the next sterilization tray was put on top.The photos provided show the sample received.A device history record review was completed for provided material number 306546, lot number 1082924.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the sterilization loading process was performed.The settings were correct and products were being placed correctly.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.
 
Event Description
It was reported that the bd posiflush¿ iv flush solution sodium chloride had a deformed tip cap.The following information was provided by the initial reporter: the customer complained that the white tip cap was found deformed.
 
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Brand Name
BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13060509
MDR Text Key286353301
Report Number1911916-2021-01284
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065463
UDI-Public30382903065463
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K003553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/05/2022
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 Expiration Date03/31/2024
Device Model Number306546
Device Catalogue Number306546
Device Lot Number1082924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2021
Initial Date FDA Received12/22/2021
Supplement Dates Manufacturer Received01/05/2022
Supplement Dates FDA Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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