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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR DL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER
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BARD ACCESS SYSTEMS 4FR DL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER Back to Search Results
Model Number N/A
Device Problem Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen3365 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reen3365) have been reported from the same facility.
 
Event Description
It was reported that when the rn engaged the safety mechanism on the introducer needle, at first it looked like it worked but when the rn picked it back up and tilted it the safety mechanism slid down the needle and did not engage.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism not activating successfully is confirmed but the exact cause could not be determined from the photo samples provided.Four photo samples of an introducer needle were provided for evaluation.The first two photos appear to show the same introducer needle in the same position.Blood residue is present within the clear hub of the needle.The safety mechanism not fully advanced over the needle bevel.The needle shaft is only passing through the proximal section of the safety mechanism with the distal section of the safety being active.The third and fourth photos show only the needle and safety mechanism.The photos show the safety mechanism rotated in two positions.The needle is still shown to only pass through the proximal end of the safety mechanism.The distal clamping portion of the safety is not threaded with the needle shaft.Based on the description of the reported event and photo samples provided, possible contributing factors include improper manipulation of the safety and safety mechanism issue.Since the condition of the needle prior to use is unknown, the exact cause could not be clearly determined.A lot history review (lhr) of reen3365 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reen3365) have been reported from the same facility.
 
Event Description
It was reported that when the rn engaged the safety mechanism on the introducer needle, at first it looked like it worked but when the rn picked it back up and tilted it the safety mechanism slid down the needle and did not engage.
 
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Brand Name
4FR DL PROVENA MIDLINE MAX BARRIER KIT
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10217683
MDR Text Key197113582
Report Number3006260740-2020-02301
Device Sequence Number1
Product Code PND
UDI-Device Identifier00801741154119
UDI-Public(01)00801741154119
Combination Product (y/n)N
PMA/PMN Number
K162900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Model NumberN/A
Device Catalogue NumberS4254108D
Device Lot NumberREEN3365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Event Location Hospital
Date Manufacturer Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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