MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	45812
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A distributor reported an issue with a bio-stable 4f sl 55cm mst-70 kit.Approximately 39 days post procedure, the picc dressing was removed, the line was flushed, and saline spurted out at around the 4cm level.Securacath was in place as well with line at 4cm external length.Per the patient, on one occasion of blood sampling, it is believed that the nurse may have used a needle next to the picc, puncturing the device.The picc was removed and replaced.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was a 4f bioflo picc.As received the 4f bioflo picc appeared used and a pin hole/slice was noted at the 4cm mark.The customer's reported complaint description is confirmed for a hole in the catheter around the 4cm marking.As described in the complaint description: per the patient, on one occasion of blood sampling, it is believed that the nurse may have used a needle next to the picc, puncturing the device.The hole in the catheter is consistent with damage from a needle puncture.This is not a manufacturing defect as also supported by fact that device was in use and leak free for more than 30 days prior to catheter hole/leak.The rest of the catheter was found to be normal in appearance.The root cause of hole in catheter tubing is handling damage during device use.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: as noted during the review of the directions for use (dfu) that is supplied in the reported kit, the following precautions/warnings are stated: warnings: do not use if package is opened or damaged.Do not fully insert catheter up to suture wing.Do not use sharp objects to open package as damage to the device may occur.If catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 12407880
• Report Number: 1317056-2021-00166
• Device Sequence Number: 4181948
• Product Code: LJS
• UDI-Device Identifier: H965458120
• UDI-Public: H965458120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 11/30/2022
• Device Model Number: 45812
• Device Catalogue Number: 45812
• Device Lot Number: 5654081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1