MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	7818518
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reaz0732 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reaz0732) have been reported from the same facility.
Event or Problem Description
It was reported that a patient said their picc was allegedly leaking so the nurse decided to change it out for a new one.When the nurse went to pull out the old picc there was allegedly none of the usual resistance and stretch, it apparently just ¿snapped¿ off.The doctor did a cut down to remove the rest of the picc.The patient was on ivig that requires d5w flushes post injection and then saline after or crystals can form in picc.No patient injury reported.This file is for second of two events reported.
Additional Manufacturer Narrative
The 30-day initial medwatch indicated that the sample had been received by the manufacturer and would be evaluated at that time.That information was incorrect; the manufacturer has not received that sample at this time.If the manufacturer does receive the sample another follow-up will be sent.A lot history review (lhr) of reaz0732 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reaz0732) have been reported from the same facility.
Event or Problem Description
It was reported that a patient said their picc was allegedly leaking so the nurse decided to change it out for a new one.When the nurse went to pull out the old picc there was allegedly none of the usual resistance and stretch, it apparently just ¿snapped¿ off.The doctor did a cut down to remove the rest of the picc.The patient was on ivig that requires d5w flushes post injection and then saline after or crystals can form in picc.No patient injury reported.This file is for second of two events reported.

• Brand Name: POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7046287
• Report Number: 3006260740-2017-02088
• Device Sequence Number: 126323
• Product Code: LJS
• UDI-Device Identifier: 00801741028533
• UDI-Public: (01)00801741028533
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 7818518
• Device Catalogue Number: 7818518
• Device Lot Number: REAZ0732
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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