• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number 300865
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problems Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914)
Event Date 06/17/2020
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone number: (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 2002284. Medical device expiration date: 2025-01-31. Device manufacture date: 2020-02-21. Medical device lot #: unknown. Medical device expiration date: 2025-01-31. Device manufacture date: 2020-02-21.
Event Description
It was reported that syringe 50ml ll caused alarms in the syringe pump. This led to hypertension in the patient. The following information was provided by the initial reporter: "we have a problem with certain lot numbers of bd plastipak syringes. We have recently had numerous occlusions, and i have tried to dissect the problem as below. I tried ringing but could not get through to your work mobile. I will escalate at our end and i have copied dave lyon in, in case there is an increase in reported incidents. I will also alert gitu / hdu etc. I guess incidents may not be noticed in areas where infusion rates are lower, as they will generate lower pumping pressures. Was the course of treatment changed? a- no, all patients required the same drug infusions as they were all essential. I was not really sure about this meaning of this question. All patients involved had their treatment interrupted because of the occlusions which occurred. After rectifying and removal of faulty syringes, the same treatment was recommenced. Any medical intervention performed? a. Yes. Patient 1: noradrenaline occlusion resulted in severe hypotension. Replacement syringe also faulty which compounded the situation. Medical input required to rectify this including short period of cpr. Other reports subsequent to this where other drugs, including propofol & morphine had either occluded, or pumping pressures were running very high. Other actions taken? a- rectification of underlying cause via removal of faulty syringes from cicu, noradrenaline episodes had datix completed. Comparison of different batch numbers of syringes an iv lines undertaken during process of problem identification. Syringe pumps in patient 1 sent to bme for inspection. Are the physical samples available for the investigation or photos? a- we have 3 bags full of the affected batch numbers of syringes on cicu, they have been placed out of the patient area in our seminar room. Hope this helps. ".
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceSYRINGE
Manufacturer (Section D)
camino de valdeolivia
san agustin de guadalix
Manufacturer (Section G)
camino de valdeolivia
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key10269514
MDR Text Key201847603
Report Number3003152976-2020-00301
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
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? Yes
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 Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2020
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: 07/14/2020 Patient Sequence Number: 1