MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 9.5F DUAL-LUMEN CV CATHETER; CHRONIC CATHETERS

Model Number 7726950

Device Problems Fracture (1260); Air/Gas in Device (4062)

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

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 04/2025.Device pending return.

Event Description

It was reported that approximately one year post catheter placement procedure, the catheter allegedly aspirated air from line repeatedly.Reportedly, the catheter was removed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 9.5 fr groshong cvc d/l catheter two segments were returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.The investigation is confirmed for the reported air or gas in device and identified fracture issues as a partial break was noted on the distal catheter segment, proximal to the tissue cuff.Upon infusion, a leak from the partial break on the distal catheter segment was observed.Furthermore, a complete circumferential breaks were noted on the distal and proximal end of the catheter segment.However, striations were noted throughout the catheter.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2025).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.

Event Description

It was reported that one year eight days post catheter placement procedure, the catheter allegedly aspirated air from line repeatedly.The device was removed and replaced.There was no reported patient injury.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER
• Type of Device: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15378478
• MDR Text Key: 305802709
• Report Number: 3006260740-2022-03501
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K860256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

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 Model Number: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: REES4338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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