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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383862
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system had a yellow piece of foreign matter on the pre-connected q-syte joint.The following information was provided by the initial reporter, translated from (b)(6): "in respiratory department, there was yellow foreign body contamination on the pre-connected q-syte joint.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system had a yellow piece of foreign matter on the pre-connected q-syte joint.The following information was provided by the initial reporter, translated from (b)(6): "in respiratory department, there was yellow foreign body contamination on the pre-connected q-syte joint.".
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system had a yellow piece of foreign matter on the pre-connected q-syte joint.The following information was provided by the initial reporter, translated from chinese: "in respiratory department, there was yellow foreign body contamination on the pre-connected q-syte joint".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/20/2022.H.6.Investigation: a device history review was conducted for lot number 1224433.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.Additionally a sample was submitted to our facility to aid in our investigation.The physical device could not be directly shipped to the manufacturing facility due to on-going shipping restrictions in the gansu province, but photographs were taken of the device and submitted.During visual analysis of these photographs our engineers were able to identify a yellow smear on the interior chamber of the q-syte component.The issue has been confirmed.Possible root cause analysis: 1.The complaint returned one defective sample and found a yellow substance in the q-syte shell.It was confirmed that the yellow substance was in the q-syte plastic shell and could not be removed.This position is in the non-flow path of the product, which does not affect the product quality and meets the product acceptance standard.2.The q-syte batch used for this batch of products is 1147568/1155223, and no abnormality is found in the inspection records of raw materials; 3.Review customer complaint history records and find that the same batch of products do not have the same defect complaint.In summary, the complaint defect is the yellow substance embedded in q-syte raw material, which cannot be removed and is not in the product flow path, meeting the product acceptance standard.H3 other text : see h.10.
 
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Brand Name
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH  215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH   215126
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13214679
MDR Text Key286327058
Report Number3014704491-2021-00427
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 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383862
Device Lot Number1224433
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2021
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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