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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER; PERIPHERAL VASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER; PERIPHERAL VASCULAR CATHETER Back to Search Results
Catalog Number 381812
Device Problem Problem with Sterilization (1596)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 bd¿ insyte autoguard shielded iv catheter had sterility breach.
 
Event Description
It was reported that bd¿ insyte autoguard shielded iv catheter had sterility breach.This malfunction affected 5 devices.
 
Manufacturer Narrative
Correction: describe event or problem: it was reported that bd¿ insyte autoguard shielded iv catheter had sterility breach.This malfunction affected 5 devices.Investigation summary: dhr review was performed on lot number 6130990; the lot number was manufacture on afa line 4 from (b)(6) 2016.Packaging line 9 from (b)(6) 2016.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.No quality notification were initiated during the build of this lot number.Received five iag 24ga units from lot number 6130990.Package was partially opened, but this is the basis of the complaint.Visual/microscopic evaluation: the product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.This characteristic was met.The key variables that affect the packaging seal are seal transfer/width and top web adhesive presence.Both variables were included in the investigation.The defect stated in the description of the complaint was confirmed with the returned units that was partially open at the top and bottom of the blister pack.Even though the packages were received partially opened, all the process characteristics that directly influence the seal were observed to be within specification.No anomalies were found.Bd supplier oliver-tolas (ot) 29lp uses a standard reinforced paper that is common to many other suppliers, but the adhesive type and application is specific to oliver-tolas.There is sufficient evidence to demonstrate the ot material or adhesive application is the root cause.Due to continuous issues with ot, bd is moving to an alternate supplier for the top web material.Capa 48637 was opened to investigate the package seal integrity complaints and implement corrective actions.
 
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Brand Name
BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER
Type of Device
PERIPHERAL VASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key8190204
MDR Text Key131194347
Report Number1710034-2018-00919
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818129
UDI-Public00382903818129
Combination Product (y/n)N
PMA/PMN Number
K952861
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 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2019
Device Catalogue Number381812
Device Lot Number6130990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Initial Date Manufacturer Received 12/05/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received12/05/2018
Supplement Dates FDA Received01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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