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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 Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 0072581.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no samples were received.No photos were provided.Therefore, sample analysis couldn¿t be performed, and the symptom reported by the customer can¿t be confirmed.A review of the applicable fmea/eura (b)(4) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause description: with no sample analysis a probable root cause could not be offered.Rationale: based on the investigation performed and with no sample analysis the symptom reported by the customer could not be confirmed; we will continue monitoring and trending the complaints to this lot and symptom this lot was produced for 360.9k units, this is a cpm of 2.7.
 
Event Description
It was reported that five 10 ml bd posiflush¿ normal saline syringes experienced difficult plunger movement during use.The following information was provided by the initial reporter: the product cannot be pushed when halfway through the bolus.
 
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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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10571314
MDR Text Key209803420
Report Number1911916-2020-00893
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2020
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 Date02/28/2023
Device Catalogue Number306595
Device Lot Number0072581
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2020
Initial Date FDA Received09/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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