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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306574
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2022
Event Type  malfunction  
Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).
 
Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).
 
Event Description
It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).
 
Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report # was sent in error.This device issue was caused by shipping incidents, not a manufacturing issue.As the problem was not caused by bd, cancelation has been requested for this complaint.
 
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Brand Name
BD POSIFLUSH¿ PRE-FILLED SALINE 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13592320
MDR Text Key286070053
Report Number3002682307-2022-00066
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
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 02/28/2022
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 Catalogue Number306574
Device Lot Number1187484
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2022
Initial Date FDA Received02/24/2022
Supplement Dates Manufacturer Received02/28/2022
Supplement Dates FDA Received03/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2021
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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