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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE ¿ INDWELLING INTRAVENOUS CATHETER; INTRAVASCUALR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE ¿ INDWELLING INTRAVENOUS CATHETER; INTRAVASCUALR CATHETER Back to Search Results
Catalog Number 388523
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd insyte ¿ indwelling intravenous catheter foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about foreign matter on needle tip.According to the customer's report, an fm was found to be adhering onto the needle tip before use.
 
Event Description
It was reported while using bd insyte ¿ indwelling intravenous catheter foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about foreign matter on needle tip.According to the customer's report, an fm was found to be adhering onto the needle tip before use.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 27-may-2022.H6: investigation summary: eight photos and one sample with open packaging were received by our quality team for evaluation.The photos were subjected to visual inspection to check for foreign matter.A strip of black loose fiber foreign matter was observed respectively on the catheter tubing and in the needle cover.The sample was subjected to visual inspection, and a strip of black loose fiber foreign matter was observed in the needle cover.The foreign matter was sent for fourier transform infrared spectroscopy (ftir) analysis to determine the foreign matter type.The results indicated that the foreign matter spectrum matches reasonably with polyoxymethylene.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.An investigation was conducted on the potential foreign matter sources ¿ material, machine, and man/environment.The two key components nearer to the foreign matter location were investigated.The catheter tubing where the foreign matter was located and the needle cover, as it might have been transferred onto the catheter tubing after assembly.The manufacturing process for both components were reviewed and no black, fibrous polyoxymethylene materials are used during production, packaging, and storage.Therefore, the materials are unlikely the source of the foreign matter.As the foreign matter is covering throughout the catheter tubing, so the entire manufacturing process was reviewed to identify the section of the process that has contact with the whole catheter tubing.The only process that comes into contact with the whole catheter tubing is the flaring station, where two rubber pads hold onto the tubing and move it downwards to assemble to the metal wedge.Based on the material specification provided by the rubber pad supplier, the rubber pads are made of neoprene rubber (polychloroprene), which does not match with the foreign matter type.Therefore, the flaring station is unlikely to be the foreign matter source.All the machines on the production line are fully covered, surfaces that are in contact with the product are cleaned periodically per the cleaning schedule.The lint-free cloth that is used to clean the machine surfaces is white in color, and is made from poly(ethylene terephalate), which does not match the foreign matter type.Therefore, the machines are unlikely to be the foreign matter source.The personal protective equipment (ppe) used in the production area were looked into to identify those with similar characteristics of foreign matter.The ppe closest in color with foreign matter is the cleanroom smock, however this is dark blue not black, and is made of poly(ethylene terephthalate) which does not match with the foreign matter.Therefore, the man / environment is unlikely to be the source of the foreign matter.As there is no black, fibrous polyoxymethylene material found in on the components, or used in the machines and man / environment, the actual foreign matter source could not be identified.As the sample was returned in open packaging, the actual root cause could not be established.
 
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Brand Name
BD INSYTE ¿ INDWELLING INTRAVENOUS CATHETER
Type of Device
INTRAVASCUALR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14639049
MDR Text Key301506400
Report Number8041187-2022-00293
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
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 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number388523
Device Lot Number1230800
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2021
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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