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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS¿ I.V. CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS¿ I.V. CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382412
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
It was reported that 11 bd angiocath plus¿ iv catheters experienced damaged catheters.The following information was provided by the initial reporter: the thickness of the catheter is not uniform and the thickness of the tip is particularly different.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 07-oct-2022.H6: investigation summary: one photo and eleven samples in open packaging were received by our quality team for evaluation.The photo was subjected to visual inspection to check for catheter damage.From the photo, the catheter adapter was observed to not be fully seated in the needle hub.However, the team was unable to observe damage on the catheter tubing.The samples were subjected to visual inspection to check for catheter damage.From sample #1, an incomplete device was returned (without the catheter tubing), therefore the team was not able to evaluate the reported defect.For samples #2, 3, 6, 7, and 10, no damage was observed on the catheter tubing under 20x magnification.For samples #4, 5, 8, 9, and 11, an uneven catheter tubing surface was observed under 20x magnification due to small lumps or droplets of transparent, gel-like substance.However, the lubricant appearance was found to be acceptable.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.The gel-like substance was most likely excessive lubricant that aggregated and formed small droplets / lumps on the catheter surface.Given the gel-like nature of the lube, it is possible for the lubricant to flow to different locations on the catheter during transportation or storage.Current quality controls include a daily outgoing inspection and hourly in-process inspection to check for catheter damage.
 
Event Description
It was reported that 11 bd angiocath plus¿ iv catheters experienced damaged catheters.The following information was provided by the initial reporter: the thickness of the catheter is not uniform and the thickness of the tip is particularly different.
 
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Brand Name
BD ANGIOCATH PLUS¿ I.V. CATHETER
Type of Device
INTRAVASCULAR 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 Key15664356
MDR Text Key307166651
Report Number8041187-2022-00614
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382412
Device Lot Number2054654
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2022
Initial Date FDA Received10/24/2022
Supplement Dates Manufacturer Received11/23/2022
Supplement Dates FDA Received12/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2022
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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