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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE VIALON-E IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE VIALON-E IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 388434
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd insyte¿ vialon-e iv catheter packaging had a hole in it.The following information was provided by the initial reporter, translated from (b)(6) to english: "the correct issue was "packages have a hole which may be caused by needle pierced through packages".".
 
Manufacturer Narrative
H6 investigation: three photos and ten actual samples were received by our quality team for evaluation.From the returned photos, a hole in the top web was observed.In four of the ten returned samples, a hole can be observed in the top web.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The secondary process was reviewed.There are four locations where this nonconformance might have occured.Simulations were performed on the four locations.The first simulation was performed on the stopper and found that if the stopper was hit on the blister pack, the duplicated sample does not match the returned sample as the contact point does not match.The second simulation was performed on the flipper plate and found that in the event of two blister packs are stacked at an inclined position, there is a possibility to cause package damage like the complaint photo, however there is a low possibility to have this occurance.The third simulation was performed on the vacuum suction cup, and found that the suction cup is made by rubber hence does not duplicate the damage point.The fourth simulation was also performed on the vacuum suction cup, this suction cup comes in contact with the bottom web, and also does not duplicate the damage point.Based on the simulation, if there are stoppageds at either location three or four, the associates remove the parts from the station and manually puts it back on the conveyor belt before loading to the flipper plate at location two, there is a chance of causing a double stack of blister packs.The current controls in place to prevent this nonconformance include a sensor to detect the moving of a part, the stopper will be triggered and activated, visual inspection and water leak tests are performed hourly to check for damaged packages, an hourly in-process inspection is performed, and a water leakage test and visual inspection is performed during outgoing inspection.The probable root cause of this nonconformance is likely human error.
 
Event Description
It was reported that the bd insyte¿ vialon-e iv catheter packaging had a hole in it.The following information was provided by the initial reporter, translated from japanese to english: "the correct issue was "packages have a hole which may be caused by needle pierced through packages".".
 
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Brand Name
BD INSYTE VIALON-E IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key10793149
MDR Text Key216414668
Report Number8041187-2020-00712
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
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 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2024
Device Catalogue Number388434
Device Lot Number9024657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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