MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POLY PER-Q-CATH® PICC CATHETER AND MICROEZ® SAFETY MICROINTRODUCER, FULL TRAY; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3153108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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 rezl0337 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
On 5/11/16 - it was reported by the complainant that during surgery over the weekend, a picc was used on a patient.When the stylet was removed from the patient it was noted that a fragment of the stylet was broken off 20 centimeters from the distal end.Patient had to be sent to another facility for retrieval of the broken piece.On 5/12/16 - received an email with additional information regarding the event.Contact reported that the fragment of the stylet was removed successfully.No harm to the patient was reported.

• Brand Name: POLY PER-Q-CATH® PICC CATHETER AND MICROEZ® SAFETY MICROINTRODUCER, FULL 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: 5691338
• Report Number: 3006260740-2016-00240
• Device Sequence Number: 18945494
• Product Code: LJS
• UDI-Device Identifier: 00801741034817
• UDI-Public: (01)00801741034817(17)170531(10)REZL0337
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2016

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: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 3153108
• Device Lot Number: REZL0337
• 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: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1