MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POLY MIDLINE 4F FULL TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER); MIDLINE CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of reew2786 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported "the gloves in the kit keep ripping" additional info.Received 01/04/2021: "there was no harm to patient, new gloves were obtained and procedure completed.The gloves ripped and were thrown away.The occurrence happened most of december with reew2786 lot numbers on midline kits.".

• Brand Name: BARD POLY MIDLINE 4F FULL TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER)
• 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: 11236630
• Report Number: 3006260740-2021-00058
• Device Sequence Number: 11723178
• Product Code: PND
• UDI-Device Identifier: 00801741037658
• UDI-Public: (01)00801741037658
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K001901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4154108
• Device Lot Number: REEW2786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/27/2021
• 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: Other