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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381212
Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/11/2017
Event Type  Injury  
Manufacturer Narrative
The customer provided four potential lot numbers for this incident. The information for each lot number is as follows: medical device lot #: 6141428, medical device expiration date: 5/31/2021, device manufacture date: 5/20/2016. Medical device lot #: 6053154, medical device expiration date: 2/28/2021, device manufacture date: 2/22/2016. Medical device lot #: 5354408, medical device expiration date: 12/31/2020, device manufacture date: 12/20/2015. Medical device lot #: 6113190, medical device expiration date: 4/30/2021, device manufacture date: 4/22/2016. Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that a 24 g x. 75 in bd insyte¿ peripheral iv catheter broke off at the hub while it was being removed from a patient (a dog). The dog received several x-rays and it appears that the catheter is stuck in the dog's vein. No additional information was provided.
 
Manufacturer Narrative
Results: six unused samples in sealed packages were returned for evaluation. A visual inspection of all units revealed no abnormalities. A review of the device history records for the potential lot numbers 6141428, 6053154, 5354408, and 6113190 revealed no irregularities during the manufacturing process. A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue. Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
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Brand Name24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6535785
MDR Text Key74145546
Report Number8041187-2017-00040
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381212
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Yes
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: 05/01/2017 Patient Sequence Number: 1
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