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

Catalog Number	H965458810
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the used sheath will be returned to angiodynamics, however it has not yet arrived.The sheath is a purchased component, so the supplier, (b)(4), will be provided with a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not yet returned to manufacturer.
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), while placing a picc, the user tried to pull the tear-away sheath and the wings broke off.The user was forced to remove the sheath over the picc line.All of the sheath was removed, i.E., no patient complications/injury.
Additional Manufacturer Narrative
The initial event description, prior receipt of the device sample, stated that both sheath handles detached from the tubing.Based on a review of the sample, however, only one handle had detached from the sheath tubing, therefore there was no risk of the sheath tubing migrating into the vessel (i.E., this would not be considered an mdr-reportable event).As an initial medwatch had already been submitted, this supplemental medwatch will provide the results of the device evaluation.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.Similar complaint trend review.The october 2016 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "sheath handle detached - one." no adverse trend was identified.As the sheath/dilator is a purchased device for angiodynamics, the returned sample, along with a supplier corrective action request (scar) was forwarded to our supplier, (b)(4).(b)(4) determination as to the root cause of this event is the sheath handle was not properly molded and contained incomplete fin fill.Additional root cause investigation will be addressed through a capa at (b)(4) medical.(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: 5708820
• Report Number: 1317056-2016-00079
• Device Sequence Number: 236904
• Product Code: LJS
• UDI-Device Identifier: H965458810
• UDI-Public: H965458810
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2016

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: 08/31/2017
• Device Catalogue Number: H965458810
• Device Lot Number: 4928850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2016
• Supplement Report FDA Received Date: 02/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR