MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERMIDLINE CATHETER (5F) (DUAL-LUMEN) (20CM)

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recw1964 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the rn attempted to place midline catheter.It was stated that the rn removed the introducer needle, inserted the dilator/introducer sheath and attempted to remove the wire but it was stuck.The rn pulled on the wire and the end broke off inside the patient.The rn placed a tourniquet at top of arm and notified physician.It was stated that the rn did not try to remove the wire when the needle was in place.On 8/1/2019- additional information reported stated, "the patient was sent to the hospital and cleared and no negative out comes were had.The guidewire was frayed.".

• Brand Name: BARD POWERMIDLINE CATHETER (5F) (DUAL-LUMEN) (20CM)
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8889011
• Report Number: 3006260740-2019-02379
• Device Sequence Number: 2587706
• Product Code: PND
• UDI-Device Identifier: 00801741144806
• UDI-Public: (01)00801741144806
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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 Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000798
• Device Lot Number: RECW1964
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/13/2019
• 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