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

Catalog Number	H965750141
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics, however the evaluation of the sample has not yet been completed.Following the conclusion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by nurse pro plus, an iv services company, picc placed at (b)(6) medical center developed a "pin hole in the extension (tubing) causing leakage." the line was removed and replaced.The patient condition was reported as "unaffected" and the device has been returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and picc assembly component lots 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 january 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode, "oversleeve - extension tubing/hole fracture." no adverse trend was identified.Visual inspection of the returned catheter confirmed that there was a hole/slice in the extension tubing {blue clamp side}.No manufacturing non-conformances or out of specification conditions were observed during the sample evaluation.Measurements were taken using pin gauges and calipers of the extension tubing id and od.Both were found to meet specification.While a definitive root cause for the damage to the device could not be determined, the slice in the extension tubing was potentially caused by a scalpel or scissors, and occurred during use of the device.Angiodynamics' process controls for the bioflo picc include 100% visual inspection for damaged tubing, 100% guidewire insertion testing to verify lumen patency, followed by 100% leak testing.The directions for use supplied with the reported picc contains the cautions, " do not use sharp instruments near the extension tubes or catheter shaft," and "do not use scissors to remove the dressing, as this may possibly cut or damage the catheter." ((b)(4)).

• 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: 6349707
• Report Number: 1317056-2017-00017
• Device Sequence Number: 474889
• Product Code: LJS
• UDI-Device Identifier: H965750141
• UDI-Public: H965750141
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: H965750141
• Device Lot Number: 5116405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1