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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50ML LUER-LOK SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK 50ML LUER-LOK SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243)
Event Date 06/17/2020
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 2002299. Medical device expiration date: 2025-01-31. Device manufacture date: 2020-03-02. Medical device lot #: 2002284. Medical device expiration date: 2025-01-31. Device manufacture date: 2020-02-21. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that bd plastipak¿ 50ml luer-lok syringe was used and the patient blood pressure dropped repeatedly. The norad pump alarmed occlusion on multiple occasions during use. The following information was provided by the initial reporter: patient arrived from cardiac theatres at 19:15 16. 6. 20 following cabgx4. Initially patient hemodynamically stable. At around 20:00 patient spontaneously dropped blood pressure to 60-70 systolic- iv fluid boluses given and noradrenaline increased. At approx. 20:30 patient significantly dropped bp again to 50-60 systolic and norad pump alarmed 'occlusion'. Again, iv fluid given and norad increased. Nurse in charge advised to change noradrenaline syringe at this point as recent similar incidents had happened with other patients on the unit relating to noradrenaline. I drew up another syringe of noradrenaline, new electrocath, pump and lumen on the cvc was used. Patient continued to be hemodynamically unstable overnight and on numerous times dropped blood pressure but norad pump did not alarm. The patient was then treat as hypovolemic and iv fluid (4l) was given overnight. At approx. 04:10 patient again significantly dropped bp to 30 systolic- inadequate cardiac output but no change to ecg trace on monitor. Approx 30 seconds of cpr commenced and iv fluid given. Norad pump then alarmed 'occlusion' again. Metaraminol boluses given by anaesthetist and patient bp rose to 60-70 systolic and remained like this until approx 04:30. Norad syringe, pump, line and lumen changed again. Patient then remained stable until the end of my shift at 07:30. Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier). As stated in description, norad pump, syringe, line and lumen on cvc was changed at each time pump alarmed 'occlusion'. Anaesthetist surgeon was contacted and aware of patients instability regularly overnight and patient was reviewed by surgeon when bp dropped. Cxr performed at approx 22:00 and echo performed at 04:30. Nurse in charge aware of patient overnight and clinical educator informed in the morning to conduct investigation. Confirmed details above. Patient stabilised once syringe changed. A sample of all lot numbers and infusion lines tested. Confirmed it was not the infusion pumps (serial no infusion pumps 03743/03483), however infusion pumps sent to bme just for clarification. Further incident datix w209641 on the 17/6/20 with the same issue. Syringe changed and patient stabilised. All syringes with batch numbers 2002299 & 2002284 removed. Escalated to appropriate personnel. Staff informed via email and poster displayed on unit. Discussed with procurement 18/6/20 re-supply of alternative syringes. Will ring bd plastipak and also escalate to medical safety device committee for ongoing plan.
 
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Brand NameBD PLASTIPAK 50ML LUER-LOK SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10272115
MDR Text Key200460373
Report Number3003152976-2020-00307
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot NumberSEE H.10
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 Received06/24/2020
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 Treatment Data
Date Received: 07/14/2020 Patient Sequence Number: 1
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