MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN IMPLANTABLE PORT D/L

Model Number	0607100
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during port placement, the guide wire allegedly broke inside the patient.Allegedly, this resulted in a longer stay in anesthesia unit with additional x-ray imaging.The patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: the device was not returned.The investigation is inconclusive for the alleged guidewire detachment as no objective evidence was provided for review.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Based on the description of the reported event, possible contributing factors include damaged guide wire and insertion technique.
Event or Problem Description
It was reported that during port placement, the guide wire allegedly broke inside the patient.Allegedly, this resulted in a longer stay in anesthesia unit with additional x-ray imaging.The patient status is unknown.

• Brand Name: HICKMAN IMPLANTABLE PORT D/L
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7660909
• Report Number: 3006260740-2018-01615
• Device Sequence Number: 2063475
• Product Code: LJT
• UDI-Device Identifier: 00801741026072
• UDI-Public: (01)00801741026072
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K912702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0607100
• Device Catalogue Number: 0607100
• Device Lot Number: REBS0662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: Required Intervention