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

Catalog Number	H965458890
Medical Device Problem Codes	Product Quality Problem (1506); Unstable (1667)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although a sample is not expected to be returned, the investigation into this reported event is on-going.The sheath/dilator is a purchased device for angiodynamics, and our supplier, galt medical, will be notified via a supplier corrective action request (scar).A supplemental medwatch will be submitted once the investigation is complete.(b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6), "the peel-apart sheath and dilator (packaged with the bioflo picc) will not lock together resulting in separation on insertion to the vessel and.On one occasion a haematoma.".
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 october 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure modes "sheath locking hub issue" and "patient injury - hematoma." no adverse trends were indicated.No sample was returned for evaluation.The introducer component is supplied to angiodynamics by the supplier galt medical.A supplier corrective action response (scar) was issued to the supplier, (b)(4) for dhr review of supplier lot and notification of the event.Galt medical could not investigate the issue without a sample, however indicated that a possible root cause for these occurrences might be because of the tip of the tearaway sheath was inserted without dilator tube support due to locking ball damage or the wrong insertion technique by end user.A process capa has been initiated by galt to determine if there are any potential improvements to the manufacturing process or design for the dilator or tearaway sheath to prevent future occurrence to locking ball issue of the sheath/dilator assembly.Pr (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: 6893321
• Report Number: 1317056-2017-00076
• Device Sequence Number: 19009348
• Product Code: LJS
• UDI-Device Identifier: H965458890
• UDI-Public: H965458890
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: Other Health Care Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: H965458890
• Device Lot Number: 5158457
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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