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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306595
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2023
Event Type  malfunction  
Event Description
It was reported that the bd posiflush¿ pre-filled saline syringe experienced foreign matter in fluid path.The following information was provided by the initial reporter: the material department reported to the dealer, saying that when the product was inspected before use, it was found that there was a black foreign matter near the salt water in the pre-fill and screw interface; samples can be returned with photos provided;.
 
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary it was reported there was a black foreign matter near the saline in the pre-filled syringe and screw interface.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a syringe with no packaging flow wrap.The syringe has discoloration at the bottom of the syringe barrel.No other defects or imperfections were observed.A device history record review was completed for provided material number 306595, lot 2096966.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.
 
Event Description
It was reported that the bd posiflush¿ pre-filled saline syringe experienced foreign matter in fluid path.The following information was provided by the initial reporter: the material department reported to the dealer, saying that when the product was inspected before use, it was found that there was a black foreign matter near the salt water in the pre-fill and screw interface; samples can be returned with photos provided;.
 
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Brand Name
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
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
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key16678214
MDR Text Key312797210
Report Number1911916-2023-00202
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeCH
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 04/04/2023
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 Number306595
Device Lot Number2096966
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/16/2023
Initial Date FDA Received04/04/2023
Supplement Dates Manufacturer Received04/04/2023
Supplement Dates FDA Received04/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2022
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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