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

Catalog Number	H965458870
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Swelling (2091); Skin Inflammation (2443)
Date of Event	01/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number ((b)(4)) in order to ascertain the last three lots shipped to the reported hospital in the six months prior to the procedure date.The device history records for the lots obtained through the shr 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 (b)(6) 2015 (b)(4) complaint report was reviewed for the bioflo picc product family and the failure mode "patient injury - infection." no adverse trend was identified.The root cause of the patient allergic reaction/infection could not be determined as the device was not returned for evaluation.There have been no other reported complaints for this or any other bioflo picc lot for this failure mode.Potential contributing factors for patient adverse reaction include the picc placement procedures and device care and maintenance.Directions for use are included with the bioflo picc device and cautions against infection.The patient has been made aware that all of the bioflo piccs she had were made from the same catheter material.
Event or Problem Description
Report called in by patient.Has previously had 3 bioflo piccs in place with no issues.A 4th.Picc was placed on (b)(6) 2016 in the ir at (b)(6) mc in (b)(6).It was place on the patient's right side chest and tunneled in place.The patient is complaining of her skin being swollen and redness in the tunneled region.She said she had "been very sick" since the placement procedure and wanted to see if this was caused by any materials in the new picc.There are many other factors that could be causing her illness, wanted to rule out the picc, itself.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5616531
• Report Number: 1317056-2016-00018
• Device Sequence Number: 15467
• Product Code: LJS
• UDI-Device Identifier: H965458870
• UDI-Public: H965458870
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K133264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 01/15/2016

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?: No
• Operator of Device: Patient Family Member or Friend
• Device Catalogue Number: H965458870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2016
• Initial Report FDA Received Date: 04/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR