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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ BD LUER-LOK¿ 18G IV 1.2X45MM 80 ML/MIN; INTRAVASCULAR CATHETER
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BECTON DICKINSON BD VENFLON¿ BD LUER-LOK¿ 18G IV 1.2X45MM 80 ML/MIN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391453
Device Problems Material Puncture/Hole (1504); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Investigation summary : 1.Exec summary - no physical device samples were returned.There are no samples and 2 photographs received from the customer along with the reported complaint of catheter tip integrity.Since the original sample could not be used, the investigating team has used the retention samples of mat.No.391453 and lot no.1125200 for investigating the reported defect.The simulation was carried out on 10 retention samples for needle penetration force, and all samples showed no needle passing through catheter in them.A chance of misalignment or damages of such kind can occur if there is a positive trim of catheter vs needle, positive trim is when the catheter length is longer than the needle.This could occur during manufacturing on the machine(stations) the team identified three places(stations) which can contribute to these defects: the three stations of station 8, station 15 and station 18 showed the following: loose/ excess pulling was happening at station # 8- occasionally.Station # 15 blade changing frequency of 30 minutes but not monitored (this one cuts the catheter with respect to needle length) station # 18 centering was getting disturbed in rare frequency due machine vibration.These occasional or rare changes on three stations would impact on having a catheter cut higher than the needle leading to positive trim.Positive trim leads to needle being smaller in length than catheter and thus will pass through the catheter during inserting into the vein.All these stations have now been corrected to eliminate the rare occurrence of these probable root cause.A review of the complaint lot history check was performed and this is the 2nd related complaint for (catheter tip integrity) on this lot # 1125200.No non-conformances were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - a lot history review for this batch # 1125200 was carried out and no related non conformances were raised in association with these packaged lots concluding all inspections were performed as per the applicable operations and met qc specifications.
 
Event Description
It was reported that 1 bd venflon¿ bd luer-lok¿ 18g iv 1.2x45mm 80 ml/min had needle through the catheter issues.The following information was provided by the initial reporter : the user facility reported that the vascular access of the patient was entered with a venflon 18g (green) catheter and the tip of the catheter was broken.
 
Event Description
It was reported that 1 bd venflon¿ bd luer-lok¿ 18g iv 1.2x45mm 80 ml/min had needle through the catheter issues.The following information was provided by the initial reporter : the user facility reported that the vascular access of the patient was entered with a venflon 18g (green) catheter and the tip of the catheter was broken.
 
Manufacturer Narrative
Supplementary ¿ corrections : the following fields were updated owing to the previous submission with incorrect imdrf annex a code : h.4.Medical device problem code - corrected to a041001.H3 other text : see h.10.
 
Event Description
It was reported that 1 bd venflon¿ bd luer-lok¿ 18g iv 1.2x45mm 80 ml/min had needle through the catheter issues.The following information was provided by the initial reporter : the user facility reported that the vascular access of the patient was entered with a venflon 18g (green) catheter and the tip of the catheter was broken.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 12-nov-2022.H6.Investigation summary: samples and photos were received by bd for evaluation.A quality engineer was able to review the two pictures and inspect the returned samples for the reported issue of catheter tip damaged from lot # 1125200 product # 391453.The investigating team has also used the retention samples of lot # 1125200 product # 391453 for investigating the reported defect.The investigation and simulation were carried out on retention samples where the investigating team has visually tested the samples for catheter tip damaged and no catheter tip damaged was found in the retention samples.The sample returned confirmed the root cause to be due to positive trimming of the needle and the catheter as seen in the sample.
 
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Brand Name
BD VENFLON¿ BD LUER-LOK¿ 18G IV 1.2X45MM 80 ML/MIN
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14639587
MDR Text Key296061320
Report Number2243072-2022-00784
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTU
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,Followup
Report Date 11/08/2022
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 Number391453
Device Lot Number1125200
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2021
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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