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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306546
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1116333, medical device expiration date: 04/30/2024, device manufacture date: 04/26/2021.Medical device lot #: 0293987, medical device expiration date: 09/30/2023, device manufacture date: 10/19/2020.Investigation summary: it was reported by the medical professional that the pre-filled syringe would not flush.As a sample was unavailable for return, a thorough sample investigation could not be completed.It could be possible that the customer is getting some products that are towards the high specification limit and are related to the symptom reported by the customer since they require extra force than normal to expel the solution.A device history record review was completed for provided material number and lot numbers.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Previous investigations have revealed that improper silicone application within the syringe barrel can create plunger resistance.Several quality initiatives have been implemented on our manufacturing line to ensure that the silicone application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the silicone is uniformly applied to the syringe barrel.Based on the investigation and with no 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.
 
Event Description
It was reported two syringe 10ml reg pr saline 10ml fill had difficult plunger movement.The following information was provided by the initial reporter: "i was in ct earlier this week and 5 minutes after i started the iv the techs told me it wouldn't flush.I felt it was a good iv and didn't want to give up on it and i tried to flush it with a different syringe and it flushed fine.Picc nurse actually restarted an iv a while back because it wouldn't flush when she discovered it was the flush, not the line.".
 
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Brand Name
SYRINGE 10ML REG PR SALINE 10ML FILL
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12475549
MDR Text Key271519276
Report Number1911916-2021-00987
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/02/2021
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 Health Professional
Device Model Number306546
Device Catalogue Number306546
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/18/2021
Initial Date FDA Received09/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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