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

Catalog Number	H965750121
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While it has been indicated that the device from the reported event will be returned to angiodynamics for evaluation, it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported picc line placed on dec 1.By dec 9, the line was not able to be infused or to provide a blood return.After performing an over-the-line replacement, the hospital examined the picc line upon withdrawl and found it to be occluded proximally.The used picc will be returned to angiodynamics for evaluation.No patient injury or complications were reported.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and 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 recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "catheter occluded." no adverse trend was indicated.In addition, this is the only reported complaint for this failure mode in the past 15 months for the bioflo picc product family.Upon visual inspection of the returned sample, the catheter tubing appeared to be occluded with unknown foreign material between the 3cm and 4cm mark.The supplied picc was found to be occluded with a piece of foreign matter, which appears to be a silicone tube similar to the hub or handle from a stiffening stylet (part #10045816) which is supplied to the end user hospital with the bioflo picc.The most likely root cause is that the end user put the incorrect end of the stiffening stylet in the picc.If the handle then got lodged and pulled off it would leave the silicone tube in the catheter.(pr21370).

• 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: 8304537
• Report Number: 1317056-2019-00028
• Device Sequence Number: 16390266
• Product Code: LJS
• UDI-Device Identifier: H965750121
• UDI-Public: H965750121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 07/31/2020
• Device Catalogue Number: H965750121
• Device Lot Number: 5383079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1