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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 11/03/2020

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.

Event Description

It was reported that the device was removed due to a vein thrombosis.No other information was provided.

Event Description

It was reported that the device was removed due to a vein thrombosis.No other information was provided.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of midline related vein thrombosis was inconclusive due to the nature of the reported event.The product returned for evaluation was one 18ga x 10cm powerglide pro rt midline catheter.Usage residues were observed throughout the sample and the sample was received with an attached extension tube.The catheter exhibited curved shape memory but was otherwise unremarkable to gross inspection.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.Microscopic inspection of the sample did not reveal any damage or deformity.No device deficiencies were discovered during evaluation of the returned sample; however, the reported event of vein thrombosis could neither be verified, nor related to the use of the implicated midline catheter.Consequently this complaint is complaint is inconclusive.H3 other text : evaluation findings are in section h.11.

• 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
• MDR Report Key: 10907345
• MDR Text Key: 218496798
• Report Number: 3006260740-2020-20682
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention