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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; HEPARIN, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; HEPARIN, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306413
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that scale markings were missing on the bd posiflush¿ heparin lock flush syringe.This event occurred 2 times.The following information was provided by the initial reporter: once they took the syringe out from the wrapper, the inner syringe was unlabeled.
 
Event Description
It was reported that scale markings were missing on the bd posiflush¿ heparin lock flush syringe.This event occurred 2 times.The following information was provided by the initial reporter: once they took the syringe out from the wrapper, the inner syringe was unlabeled.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 01-apr-2022.Possible lot numbers.D4: medical device lot #: 129482n.D4: medical device lot #: 131833n.D4: medical device expiration date: 30-apr-2023.H4: device manufacture date: 25-feb-2022.H6: investigation summary: it was reported the inner syringe was unlabeled.To aid in the investigation, three samples were received for evaluation by our quality team.A visual inspection was performed.One sample has no syringe barrel label.No other defects or imperfections were observed.This defect could occur if there was a jam at the labeler machine inducing the missing syringe barrel label.For the 'unknown' lot provided a device history record review could not be completed.A device history record review was completed for additional lot numbers 129482n and 131833n.The review did not reveal any detected quality issues during the production these lots that could have contributed to the reported defect.Verification of the labeler machine was performed.The settings were correct and the flow of products was good.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
 
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Brand Name
BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
Type of Device
HEPARIN, 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 Key13893198
MDR Text Key287905714
Report Number1911916-2022-00166
Device Sequence Number1
Product Code NZW
UDI-Device Identifier30382903064138
UDI-Public30382903064138
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/04/2022
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 Other
Device Model Number306413
Device Catalogue Number306413
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received04/04/2022
Supplement Dates FDA Received04/22/2022
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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