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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER INTRAVENOUS CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER INTRAVENOUS CATHETER Back to Search Results
Catalog Number 388412
Device Problems Component Missing (2306); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation results: 4 photos were returned for investigation. 2 actual samples in opened packaging from batch 3322452, and batch 5324029 were returned for investigation. Our quality engineer inspected the returned units and photos, and confirmed the reported complaint but could not identify any manufacturing related defects. The actual sample from batch 5324029 was found to be empty. A device history record review was conducted for both batches and no quality notification was raised for similar nonconformance during the production of the batches. Conclusions: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal areas, which was present on both returned samples showing that the sealing process was completed in manufacturing facility. Therefore, no assignable root cause can be established. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 5324029, medical device expiration date: 2020-11-30, device manufacture date: 2015-12-21. Medical device lot #: 3322452, medical device expiration date: 2018-11-30, device manufacture date: 2014-01-06. 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 before use, a bd insyte¿ iv catheter was found with a breach of package integrity as well as missing supplies. No report of injury or medical intervention reported.
 
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Brand NameBD INSYTE¿ IV CATHETER
Type of DeviceINTRAVENOUS 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 Key7164433
MDR Text Key251789771
Report Number8041187-2017-00283
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K942045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2018
Device Catalogue Number388412
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
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: 01/04/2018 Patient Sequence Number: 1
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