MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD MIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.

Event Description

It was reported "i wanted to let you know of a mishap we had a couple of weeks ago in placing a midline.A very experienced nurse was placing the midline and has never had any issues.When he placed this one as he was pulling the catheter back it stopped and could not pull back, it then popped and basically broke off in the pts arm.The surgeon came and after making a tiny slit in the arm was able to remove the end of the catheter that had broken off and there was part of the guide wire that had uncoiled and broke off in the catheter as well.The pt has done fine from the incident but i wanted to pass this on to you in case others had been reported.".

• Brand Name: BARD MIDLINE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10681178
• MDR Text Key: 211427607
• Report Number: 3006260740-2020-20127
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention