MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 3F SINGLE-LUMEN MIDLINE WITH SAFETY INTRODUCER INTERMEDIATE TRAY; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	4143202
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rear0339 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Per sales representative, facility contact stated that the hub of a per-q-cath "snapped" off when inside the patient.The nurse was able to grab the catheter and the line was removed.No patient injury reported.Awaiting additional event details from facility contact including if a new catheter was placed.On (b)(6) 2016 - additional information reported by nurse stated that a new catheter was placed in the patient and that there was no patient injury.No additional medical treatment was required.

• Brand Name: PER-Q-CATH PLUS 3F SINGLE-LUMEN MIDLINE WITH SAFETY INTRODUCER INTERMEDIATE TRAY
• Common Device Name: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5901441
• Report Number: 3006260740-2016-00452
• Device Sequence Number: 10921642
• Product Code: NIE
• UDI-Device Identifier: 00801741074936
• UDI-Public: (01)00801741074936(17)180328(10)REAR0339
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

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: 03/28/2018
• Device Catalogue Number: 4143202
• Device Lot Number: REAR0339
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1