MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT BARD POLY MIDLINE; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of reeu0287 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported via ms&s "caller states a few weeks ago he had his midline taken out.He states he now feels pain and tenderness a few inches from where the port was inserted.Caller asking if he should contact his doctor about this.Also what could be causing this issue." ms&s response "explained that he should contact his physician about this pain in his arm.Explained that some medications can irritate the vessels of the upper arm when they are given via a midline.Explained that this irritation can cause residual inflammation in the vein.It could also be something more serious like an infection or blood clot.The only way to know for sure is to have it evaluated further by his physician." additional information received 03/22/2021: concomitant therapy: "saw dr.On (b)(6), vein hard and sore, diagnosed a blood clot, prescribed 15 minute heat therapy three times a day, contact him if worse, report condition in 5 days.".

• Brand Name: DOT BARD POLY MIDLINE
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11655460
• Report Number: 3006260740-2021-01289
• Device Sequence Number: 3538127
• Product Code: PND
• UDI-Device Identifier: 00801741121609
• UDI-Public: (01)00801741121609
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: N/A
• Device Catalogue Number: CK000495A
• Device Lot Number: REEU0287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/13/2021
• 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
• Patient Age: 73 YR
• Patient Weight: 70