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

Catalog Number	H965458320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no lot number was provided, a ship history report (shr) was generated to determine the last 3 lots shipped to the reporting customer in the 6 months prior to the procedure date.A review of the device history records was performed for the packaging and component lots obtained through the shr 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 for the failure mode "hub broken/cracked." no adverse trends were indicated.The complaint of a cracked hub was confirmed through photographs provided and examination of the returned device: the catheter was returned with caps attached to each luer.Excessive force was required to remove the needleless connector from the white valved hub prior to the disinfection process.When the cap was able to be removed (with hemostats), a piece of the white hub broke away.The likely root cause for the reported crack is an over-tightened connection with a mating male luer (likely a needleless connector).Inadequate flushing of the device may also be a contributing factor.The directions for use (dfu) supplied with the reported picc device contains caution that "repeated overtightening may reduce hub connector life," and not to use hemostats to "secure or remove devices with luer lock hub connections." recommended flushing techniques are also stated in the dfu.(b)(4).
Event or Problem Description
As reported by angiodynamics' (b)(4), indwelling bioflo picc was removed due to a cracked hub.Picc was being used for the delivery of tpn.No patient injury or complications were reported.

• 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: 8285038
• Report Number: 1317056-2019-00013
• Device Sequence Number: 2462567
• Product Code: LJS
• UDI-Device Identifier: H965458320
• UDI-Public: H965458320
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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 Catalogue Number: H965458320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1