MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (18G) (10CM)

Model Number N/A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

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.Device not returned for evaluation.

Event Description

It was reported via medwatch "j-loop portion on midline catheter snapped and broke in two when this tubing got caught in the bedrail.Replaced midline j-loop with standard stock j-loop." no other information was provided.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (18G) (10CM)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18986809
• MDR Text Key: 338718881
• Report Number: 3006260740-2024-01315
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741139390
• UDI-Public: (01)00801741139390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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: ST018101D
• Device Lot Number: REHV2589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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