MAUDE Adverse Event Report: ANGIODYNAMICS BIOSTABLE PICC; PERIPHERALLY INSERTED CENTRAL CATHETER,

Catalog Number	H965750335
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported by the customer: a flipped/coiled line in a patient.Device was successfully removed, and th patient was reported as unaffected.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a bioflo pcc 5f dual lumen.As received, the catheter was returned in two pieces.The catheter was cut at the 18cm.The remainder of the catheter tubing was also returned inside the plastic bag.The hubs had a needleless connector (nc, not supplied in the reported kit) attached to it.There were no kinks, compressions or other damage noted to the returned catheter tubing.The returned sample was flushed with some difficulty using a 10ml syringe through both lumens during the disinfection process.No issues were noted.The customer's complaint description cannot be confirmed given the nature of the catheter malposition failure mode.No manufacturing non-conformances were observed during sample evaluation and the catheter tubing met dimensional specifications.Based on the evaluation performed on the returned sample, the root cause for the customer's complaint is inconclusive, as the sample was found to be visually, dimensionally and functionally acceptable.Potential contributing factors for this complaint may be catheter positioning techniques used during the placement procedure or patient anatomy.A dhr review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The dfu contains the following precautionary statements: if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not fully insert catheter up to suture wing.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: BIOSTABLE PICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8893025
• Report Number: 1317056-2019-00108
• Device Sequence Number: 372040
• Product Code: LJS
• UDI-Device Identifier: H965750335
• UDI-Public: H965750335
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: H965750335
• Device Lot Number: 5460237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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: Required Intervention