MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4FR DL PROVENA MIDLINE FULL KIT W/GUARDIVA AND PROBE COVER; MIDLINE CATHETER

Catalog Number S4254108DGP

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 04/25/2023

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

Customer reported that the tear away sheath did not fully break in two.Catheter stuck in orange part of sheath.User had to troubleshoot sheath and insert catheter by bypassing orange portion of sheath.No other information was provided.

Event Description

Customer reported that the tear away sheath did not fully break in two.Catheter stuck in orange part of sheath.User had to troubleshoot sheath and insert catheter by bypassing orange portion of sheath.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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of an improper sheath peel was confirmed and the cause appeared to be related to device manufacture.The product returned for evaluation was one photograph which depicted a 4.5fr microintroducer peel-apart sheath.The device was held in a gloved hand.Blood residue was visible on the sample and the glove.The grey sheath was completely split and one half, including the orange pull tab was not visible.The remaining pull tab was attached to one of the split grey tube halves.A ring of orange plastic was visible at the proximal end of the pull tab and a length of powerpicc catheter was visible inlaid through that ring.The material surrounding the catheter shaft was consistent with the orange plastic of the pull tab and demonstrated that the pull tabs had not split correctly during device use.The depicted device had not split correctly, as indicated in the event description.The improper fracture between the two orange pull tabs appeared to be caused by the molding/skiving process during device manufacture.Photographs have been forwarded to the manufacturing site for further evaluation.H3 other text : evaluation findings are in section h.11.

• Brand Name: 4FR DL PROVENA MIDLINE FULL KIT W/GUARDIVA AND PROBE COVER
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16924811
• MDR Text Key: 315457505
• Report Number: 3006260740-2023-01869
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154188
• UDI-Public: (01)00801741154188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162900
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: S4254108DGP
• Device Lot Number: REGZ1006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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