MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT WITHOUT SUTURE PLUGS WITH ATTACHABLE 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1808551
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or 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 device has been returned 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 the tunneler was sealed into the plastic.The device was not used on a patient.There was no reported patient injury.
Event or Problem Description
It was reported that the tunneler was sealed into the plastic.The device was not used on a patient.There was no reported patient injury.
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.Investigation summary: the device returned was one tunneler reportedly from a powerport isp mri with 8 fr s/l groshong catheter.The complaint of a tunneler extending through the plastic is confirmed and is found more specifically to be a sterile barrier breach.The tunneler appeared straight.The sample was received with original opened bottom tray.The tunneler was located in the depression in which it is normally packaged, except that the tip of the tunneler was extending through the tray material.Consultation of the packaging engineer suggested that the most likely cause was dropping the tray or outer box, such as during transport or storage.The location this occurred is uncertain.The definitive root cause could not be determined based upon available information.It is unknown if shipping or storage issues contributed to the reported event.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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT WITHOUT SUTURE PLUGS WITH ATTACHABLE 8F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7526458
• Report Number: 3006260740-2018-01017
• Device Sequence Number: 11145156
• Product Code: LJT
• UDI-Device Identifier: 00801741027109
• UDI-Public: (01)00801741027109
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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 Model Number: 1808551
• Device Catalogue Number: 1808551
• Device Lot Number: REBT0357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1