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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383914
Device Problems Delivered as Unsterile Product (1421); Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2022
Event Type  malfunction  
Event Description
It was reported that prior to using a bd pegasus¿ safety closed iv catheter system, the packages were wet and the box contained mixed lots of product.The following information was provided by the initial reporter: a box of indwelling needles just delivered to the department in the afternoon had wet outer packaging, and the inner packaging was wet after opening the box.Also, there were multiple expiry dates in a box, including (b)(6) 2022.
 
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9262951.Medical device expiration date: 08-oct-2022.Device manufacture date: 19-sep-2019.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Correction: the unknown lot# has been updated with the actual lot number.Medical device lot #: 9262951.Medical device expiration date: 08-oct-2022.Device manufacture date: 19-sep-2019.Investigation summary: a device history review was conducted for lot number 9262951.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.
 
Event Description
It was reported that prior to using a bd pegasus¿ safety closed iv catheter system, the packages were wet and the box contained mixed lots of product.The following information was provided by the initial reporter: a box of indwelling needles just delivered to the department in the afternoon had wet outer packaging, and the inner packaging was wet after opening the box.Also, there were multiple expiry dates in a box, including september 2022 and october 2022.
 
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Brand Name
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15108274
MDR Text Key304628937
Report Number3014704491-2022-00299
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/08/2022
Device Catalogue Number383914
Device Lot Number9262951
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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