MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO TECHNOLOGY; BIOSTABLE PICC

Catalog Number	750241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A nurse reported an issue with a bioflo picc (non-valved) 6ftl-55cm maximal barrier nursing kit.This kit had a probe cover packet that contained an open gel pack.The nurse reported sustaining a needle stick from the 6f kit upon cleanup of the "gooey mess," in the tray.The needlestick was with a dirty needle.The nurse had lab draws done due to risk of infection.The draws all had negative outcomes.There was no permanent harm or injury to the nurse due to this incident.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.Review of event description states that user needle stick occurred while they were cleaning tray/packaging of gel that had insufficient pouch seal.There was no indication of needle malfunction.The customer's reported complaint description of accidental needle stick injury cannot be confirmed given the nature of this user adverse event.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the reported 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.Labeling review: the dfu that is supplied in bioflo kits contains the following precaution: to activate safety mechanism, hold safety handle in one hand and rotate flashback chamber counter-clockwise.Ii.Pull back on flashback chamber until needle tip disappears into safety handle and locks securely into needle handle (indicated by audible click and feel).Iii.Verify needle tip is securely locked inside safety handle by pushing flashback chamber forward while holding safety handle.Repeat prior step, if necessary.E.Discard needle per institutional protocol.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 TECHNOLOGY
• Common Device Name: BIOSTABLE PICC
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11648307
• Report Number: 1317056-2021-00083
• Device Sequence Number: 14294583
• Product Code: LJS
• UDI-Device Identifier: H965750241
• UDI-Public: H965750241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 750241
• Device Lot Number: 5665306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/25/2021
• 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: Other