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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER

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ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER Back to Search Results
Catalog Number H96560M7801261
Device Problems Obstruction of Flow (2423); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2018
Event Type  malfunction  
Manufacturer Narrative
Although no sample is being returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
 
Event Description
As reported by hospital in (b)(6): picc placed (b)(6) 2018 - seen for occlusions (b)(6) (tpa).Incidental xray (b)(6) shows good positioning.Hd etoposide given (b)(6).Incidental xray done (b)(6) shows curl.Picc removed and replaced (b)(6).Hospital has stated that the dfu for etoposide lists polyurethane as contraindicated.
 
Manufacturer Narrative
Correction - initial medwatch, lot # should be unknown, expiration date should be unknown, device manufacture date should be unknown.In lieu of a reported lot number, a ship history report (shr) was generated for item number h96560m7801261 in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were: (5289472, 5285643 and 5277220).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the complaints reported for the bioflo picc product family and the failure mode "aspiration difficulty - removed." no adverse trend was identified.We reviewed our chemical testing associated with the bioflo picc catheter tubing and confirmed that etoposide is not a new drug and it was included in our chemical compatibility evaluation.A drug representing this class of chemotherapy agents was tested.Etoposide is generic drug name but review of one manufacturer's directions for use of their drug cautioned against using the drug undiluted.The undiluted use of the etoposide drug is a potential root cause for the issues experienced with the bioflo picc device.The end user hospital has stated that they are now diluting this drug for treatment.(b)(4).
 
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Brand Name
ANGIODYNAMICS / BIOFLO
Type of Device
PERIPHERALLY INSERTED CENTRAL CATHETER
Manufacturer (Section D)
ANGIODYNAMICS
10 glens falls technical park
glens falls NY 12801
MDR Report Key7540993
MDR Text Key109254439
Report Number1317056-2018-00088
Device Sequence Number1
Product Code LJS
UDI-Device IdentifierH96560M7801261
UDI-PublicH96560M7801261
Combination Product (y/n)N
PMA/PMN Number
K163452
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date01/31/2020
Device Catalogue NumberH96560M7801261
Device Lot Number5304149
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/27/2018
Initial Date FDA Received05/24/2018
Supplement Dates Manufacturer Received04/27/2018
Supplement Dates FDA Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age24 YR
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