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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 INTERVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR 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 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #; (b)(6). Initial reporter fax #: (b)(6). Investigation summary: two photos were received by our quality team for evaluation. The first photo shows a product label that is not for the reported batch, this unit label does not belong to any products manufactured at bd tuas. The second photo show 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, a product label that is not from the reported batch was observed. As this unit label does not belong to any products manufactured at bd tuas, this product mix could have occurred outside the tuas manufacturing process. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: probable root cause: according to the dhr review results, there was no qn raised for mix products in this packaging needle batch. From the returned photos received, it shows a product label that is not for the complaint batch. This unit label do not belong to any products manufacture in tuas. The product mix could have happened outside tuas manufacturing process. The complaint trend will be tracked and monitored.
 
Event Description
It was reported that at least one bd pegasus¿ safety closed iv catheter system experienced a mix of product types in a pack. The following information was provided by the initial reporter: during the puncture in the hospital¿s day operating room, it was discovered that 383742 unopened new indwelling needles were mixed with 2 383057 indwelling needles. The 383057 xiangma has never been sold in (b)(6). Two cases of the same incident have been discovered so far.
 
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Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key12112532
MDR Text Key262879926
Report Number8041187-2021-00562
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
PENDING
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 Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383742
Device Lot Number0297046
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 Manufactured10/23/2020
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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