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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383742
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: two photos were received by our quality team for evaluation. The first photo shows a bd intima ii product, which is not manufactured at bd tuas. The second photo shows a bd intima ii product and a pegasus product with a picture of a pegasus shelf carton. A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found. From the returned photos received, it shows that there are intima ii products found in the shelf carton for the pegasus product. As the intima ii product is not manufactured in the bd tuas plant, the product mix could have occurred outside the tuas manufacturing process. The distribution center in shanghai has begun an investigation on this nonconformance. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that unopened product from material numbers 383057 and 383057 were found in the 4 boxes of bd pegasus¿ safety closed iv catheter systems. The following information was provided by the initial reporter, translated from (b)(6) to english: "daytime operating room in the puncture found 383742 a whole box of unopened needle mixed with 383057 new needle 2, 383057. ".
 
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Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key12064168
MDR Text Key262875343
Report Number8041187-2021-00530
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383742
Device Lot Number0234440
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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