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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306546
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that the bd posiflush¿ normal saline syringe was not pre-filled to its design specifications.This event occurred 2 times.The following information was provided by the initial reporter: we received a notification from nursing today that some of the bd posiflush syringes were empty.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6).Investigation summary: it was reported two syringes were empty.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two syringes.From the photo it is not possible to confirm the symptom reported by the customer.As a sample was not returned, a thorough sample investigation could not be completed and a probable root cause could not be offered.A device history record review was completed for provided material number 306546, lot number 1263819.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.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 could not be confirmed.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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-02-10.H6: investigation summary it was reported two syringes were empty.To aid in the investigation, one sample in a sealed packaging blister and one photo were provided for evaluation by our quality team.A visual inspection was performed and the sample has no solution.The photo shows two syringes.From the photo it is not possible to confirm the symptom reported by the customer.No other defects or imperfections were observed.This defect could occur if there was a jam at the filling machine missing this syringe and inducing the symptom reported by the customer.A device history record review was completed for provided material number 306546, lot number 1263819.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the filing process was performed.The sensors were tested and an empty sample was detected.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
 
Event Description
It was reported that the bd posiflush¿ normal saline syringe was not pre-filled to its design specifications.This event occurred 2 times.The following information was provided by the initial reporter: we received a notification from nursing today that some of the bd posiflush syringes were empty.
 
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Brand Name
BD POSIFLUSH¿ NORMAL 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
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13385796
MDR Text Key286446560
Report Number1911916-2022-00027
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065463
UDI-Public30382903065463
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/11/2022
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 Health Professional
Device Model Number306546
Device Catalogue Number306546
Device Lot Number1263819
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2022
Initial Date FDA Received01/28/2022
Supplement Dates Manufacturer Received02/11/2022
Supplement Dates FDA Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
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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