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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML POSIFLUSH LA

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML POSIFLUSH LA Back to Search Results
Catalog Number 1747312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Vomiting (2144); Reaction (2414)
Event Date 08/08/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation summary: a device history review was completed regarding material number: 306565 and lot number: 0014635. 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 of this complaint, three picture samples were received for evaluation by our quality team and they all showed a syringe in its sealed packaging flow wrap. As a physical sample was unavailable for return, a thorough sample investigation could not be completed. 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. Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends. Investigation conclusion: 3 photos were provided. They all show a syringe in its sealed packaging flow wrap. Note: these are exactly the same photos reported with the complaint#: (b)(4). The complaint was filed twice. Root cause description: since no sample was received the sample analysis could not be performed and no probable root cause can be offered. Rationale: based on the investigation carried out and with no sample for analysis the symptom reported by the customer can¿t be confirmed. No additional actions will be taken other than monitoring the complaint trend for this lot. The lot was produced for 0. 967mm units; considering the 2nd complaint filed as duplicate of the 1st one. The cpm is 2. 0.
 
Event Description
It was reported that syringe 10ml posiflush la caused an allergic reaction in the patient. The following information was provided by the initial reporter: "suspected adverse reaction to medicine: nausea and vomiting. The patient has no allergies nor other previous reactions to the medication. The reaction disappeared / got better with the interruption of the medication. Other patient information are stated within patient information. ".
 
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Brand NameSYRINGE 10ML POSIFLUSH LA
Type of DeviceSYRINGE
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 Key10434333
MDR Text Key204725856
Report Number1911916-2020-00804
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number1747312
Device Lot Number0014635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/20/2020 Patient Sequence Number: 1
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