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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER
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BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problem No Patient Involvement (2645)
Event Date 06/22/2020
Event Type  malfunction  
Manufacturer Narrative
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redr0299 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redr0299) have been reported from the same facility in (b)(6).
 
Event Description
It was reported that the operator found skin scalpel and guide wire were rusted during operations on (b)(6) 2020.According to verification with the warehouse of this hospital, this department requested and received redr0229 devices on april 27 and april 28.
 
Event Description
It was reported that the operator found skin scalpel and guide wire were rusted during operations on (b)(6) 2020.According to verification with the warehouse of this hospital, this department requested and received redr0229 devices on april 27 and april 28.
 
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of corrosion within the kit was confirmed, but the exact cause could not be determined from the two photographs that were provided for investigation.Both photos showed what appeared to be a sealed package with an oxidized scalpel blade and loose particles of oxidized material within the package.The guidewire was not visible within the photo.Potential causes of the damage include exposure to high humidity; however, it is unknown where or when the humidity could have been introduced into the tray.The tyvek packaging is not a humidity barrier.Tyvek is a breathable substrate and is designed to allow air/humidity to pass through.It is possible that the kits were exposed to high humidity outside bd control.All similar complaints from this lot were reported by the same complainant.A review of the manufacturing records showed no evidence that the reported issue was caused by the manufacturing or packaging process.A lot history review (lhr) of redr0299 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redr0299) have been reported from the same facility in china.
 
Event Description
It was reported that the operator found skin scalpel and guide wire were rusted during operations on (b)(6) 2020.According to verification with the warehouse of this hospital, this department requested and received redr0229 devices on april 27 and april 28.
 
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 rusted components is confirmed; however, the exact cause is unknown.One 4.5 fr x 5 cm microez kit was returned for evaluation.An initial visual observation showed the outer and inner pouches of the kit were returned sealed.Reddish-brown colored dust and particles could be seen throughout the sealed inner pouch.A reddish-brown residue was observed on the entire blade of the scalpel within the returned kit.Once the kit was opened and the components were removed, one edge of the paper ifu was found to be wavy and slightly yellow-ish in color, perhaps from exposure to moisture.The clear film of both the inner and outer kit packaging appeared to have become delaminated into two thin layers which came apart somewhat easily.Both pouches appeared to be completely sealed.A microscopic observation revealed a reddish-brown residue on each of the components within the returned kit.A translucent whitish residue was also observed on the tip of the 20 g iv introducer needle, guidewire, and 21 g introducer needle.Potential causes of the apparent rust on the kit components, as well as the observed delamination of the clear film of the kit packaging, include exposure to high humidity and/or high temperatures.However, it is unknown when or where the kit may have been exposed to these extreme conditions.The white tyvek portion of the packaging is not a humidity barrier.Tyvek is a breathable substrate and is designed to allow air/humidity to pass through.It is possible that the kit was exposed to high humidity outside bd control.A review of the manufacturing records showed no evidence that the reported issue was caused by the manufacturing or packaging process.A lot history review (lhr) of redr0299 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redr0299) have been reported from the same facility in china.
 
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Brand Name
UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10280683
MDR Text Key199122511
Report Number3006260740-2020-02456
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00801741074530
UDI-Public(01)00801741074530
Combination Product (y/n)N
PMA/PMN Number
K915167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Model NumberN/A
Device Catalogue Number0668945
Device Lot NumberREDR0299
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Event Location Hospital
Date Manufacturer Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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