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

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2020

Event Type  malfunction  

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 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)
• Type of Device: MIDLINE CATHETER
• 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: 11236630
• MDR Text Key: 230040713
• Report Number: 3006260740-2021-00058
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741037658
• UDI-Public: (01)00801741037658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001901
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4154108
• Device Lot Number: REEW2786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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): Other