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

Catalog Number	H965750161
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the sample from the reported event will be returned to angiodynamics for evaluation, but it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by (b)(6) hospital, a patient's picc line, which had been placed in their right arm, was leaking at the extension leg.The patient's father had stated that the patient had been "pulling at the line prior to the bleeding/leaking that occurred." it was indicated that the used picc would be returned to angiodynamics for evaluation.
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 july 2017 angiodynamics complaint report was reviewed for the fluid delivery set product family and the failure mode "leaked." no adverse trend was identified.The used catheter was returned cut at the 20cm mark.Fluid was noted in the extension tube.There were no molding/manufacturing related non-conformances noted to the returned sample, nor were any kinks, compressions or other damage noted.During the cleaning process a 10ml syringe was used to infuse the cleaning solution through the valve and through the catheter.Infusion could not be performed due to the bio matter {dried blood}at the tip of the catheter tubing.The sample was soaked in the cleaning solution (bleach and warm water mixture).After the sample soaked, bio matter was able to be removed.A guidewire (0.018") was inserted through the lumens of the returned sample without difficulty, confirming patency.The catheter was primed and then clamped at the distal end.Using the 10 ml syringe, an attempt to inject fluid was unsuccessful, confirming no leakage in the catheter.The catheter was measured (tip id and tip od) using pin gauges and calipers and found to meet specification.The reported complaint of leakage was unable to be confirmed as the returned device was evaluated and found to be visually, dimensionally and functionally acceptable, i.E.Met specification at the time of manufacturing.((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: 6724719
• Report Number: 1317056-2017-00056
• Device Sequence Number: 831487
• Product Code: LJS
• UDI-Device Identifier: H965750161
• UDI-Public: H965750161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2017

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: 10/31/2018
• Device Catalogue Number: H965750161
• Device Lot Number: 5104760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR