MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER FULL KIT (4F) (SINGLE-LUMEN) (20CM)

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

Customer reported that during the venous access medication procedure, when removing the suture-less fixation device (which was removed without any problems) the white butterfly connection of the midline catheter detached completely from the device, which remained in the patient's arm.The catheter was removed.No other information was provided.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regp1784 showed no other similar product complaint(s) from this batch number.

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: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter break is confirmed.One 4 fr single lumen powermidline catheter was returned for evaluation.An initial visual observation showed the sample was returned in two pieces and use residue was observed throughout the returned sample.A microscopic observation revealed the catheter was broken at the distal end of the molded joint.The break surfaces were observed to be flat with a granular surface texture, which is indicative of a tensile failure caused by excessive pulling forces.

Event Description

Customer reported that during the venous access medication procedure, when removing the suture-less fixation device (which was removed without any problems) the white butterfly connection of the midline catheter detached completely from the device, which remained in the patient's arm.The catheter was removed.No other information was provided.

• Brand Name: BARD POWERMIDLINE CATHETER FULL KIT (4F) (SINGLE-LUMEN) (20CM)
• 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 olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16359606
• MDR Text Key: 309391075
• Report Number: 3006260740-2023-00398
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: P6154208
• Device Lot Number: REGP1784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/11/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Sex: Female