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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; PREFILLED SALINE SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; PREFILLED SALINE SYRINGE Back to Search Results
Catalog Number 306595
Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Event Description
It was reported that 5 10 ml bd posiflush¿ normal saline syringes experienced difficult plunger movement, and stopper separation from the plunger.The following information was provided by the initial reporter, translated from chinese to english: in the department of neurology, when the patient is flushed and sealed, the bolus is difficult after the pressure is released, and the push rod falls off the rubber stopper when withdrawing, and the green claims are settled.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation: it was reported when the patient is flushed and sealed, the bolus is difficult after the pressure is released and the plunger rod falls off the rubber stopper when withdrawing.To aid in the investigation, two photos were provided for evaluation by our quality team.Both photos show the plunger rod separated from the stopper.No other defects or imperfections were observed.It could be possible the customer is not using the product as intended.This product is designed to push the plunger rod down not pull it back.A device history record review was completed for provided material number 306595, lot number 1007451.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h.10.
 
Event Description
It was reported that 5 10 ml bd posiflush¿ normal saline syringes experienced difficult plunger movement, and stopper separation from the plunger.The following information was provided by the initial reporter, translated from chinese to english: in the department of neurology, when the patient is flushed and sealed, the bolus is difficult after the pressure is released, and the push rod falls off the rubber stopper when withdrawing, and the green claims are settled.
 
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Brand Name
10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
Type of Device
PREFILLED SALINE SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12857398
MDR Text Key285567563
Report Number1911916-2021-01178
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 12/07/2021
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 Date12/31/2023
Device Catalogue Number306595
Device Lot Number1007451
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2021
Initial Date FDA Received11/22/2021
Supplement Dates Manufacturer Received12/07/2021
Supplement Dates FDA Received12/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2021
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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