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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 Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2021
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.(b)(4).
 
Event Description
It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced leakage.The following information was provided by the initial reporter: the blood department opened the package for examination and found that the leakage did not cause any harm.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/26/2021.H.6.Investigation: a device history record review was completed for provided material number 306595 and lot number 0216379.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one sample was received for evaluation by our quality team.A visual inspection was performed.The sample came in the packaging blister and the barrel has a crack from the 10ml to the 7ml mark.No other defects or imperfections were observed.It could be possible for this defect to occur if a jam occurred inducing the damage to the barrel.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.
 
Event Description
It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced leakage.The following information was provided by the initial reporter: the blood department opened the package for examination and found that the leakage did not cause any harm.
 
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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
MDR Report Key11342878
MDR Text Key232359459
Report Number1911916-2021-00139
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue Number306595
Device Lot Number0216379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Date Manufacturer Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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