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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ N IV CATHETER INTRAVENOUS CATHETER Back to Search Results
Catalog Number 388411
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 a package of a bd insyte¿ n iv catheter contained mix products with a 24g that should not have been there. There was no report of exposure, serious injury, or medical intervention.
 
Event Description
It was reported that a package of a bd insyte¿ n iv catheter contained mix products with a 24g that should not have been there. There was no report of exposure, serious injury, or medical intervention.
 
Manufacturer Narrative
Investigation summary: 1 actual sample in closed packaging was returned for investigation. The unopened sample was subjected to visual inspection. Incorrect needle length from the print on top web was observed on the returned sample. Dhr review shows no quality notification was raised for similar nonconformance during the production of this batch. The probable root cause of the nonconformance could be due to the improper line clearance and change-over performed by the manufacturing associates or improper checks and verification by the quality associates when returning the inspected an samples into the good part bin. A re-training will be conducted to all manufacturing personnel on proper line clearance and changeover, and proper checks and verification are done accordingly. A re-training will be conducted to all quality personnel to check and verify the an samples¿ sku and the good bin icam number before placing the samples in the good bin, and to continue the practice of returning the samples after inspection in a separate zip lock bag.
 
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Brand NameBD INSYTE¿ N IV CATHETER
Type of DeviceINTRAVENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7975079
MDR Text Key124333003
Report Number8041187-2018-00378
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903884117
UDI-Public382903884117
Combination Product (y/n)N
PMA/PMN Number
N/A
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 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2022
Device Catalogue Number388411
Device Lot Number7051294
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/17/2018 Patient Sequence Number: 1
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