MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CATHETER 5F BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Misassembled (1398)

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

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refv2001 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in japan.

Event Description

It was reported that when opening the kit, the introducer needle with sheath did not have the sheath, and when the introducer needle was taken out of the case, the safety was locked and it could not be used.Reportedly, another kit was used to complete the procedure.There was no reported patient involvement.

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: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a prematurely activated safety mechanism is inconclusive due to the state of the returned sample.Two 5 fr dual lumen groshong nxt catheter kits were returned for evaluation.An initial visual observation showed both kits were returned open.One kit was found to contain all of the kit components except the introducer needle, and the other kit was found to only contain an introducer needle.The safety mechanism of this introducer needle was found to be activated and engaged over the needle tip.The needle guard was returned, but the cylinder of the safety mechanism was not returned.No obvious evidence of use was observed on the introducer needle.While the safety mechanism of the returned introducer needle was found to be activated, the opened state of the packaging made it difficult to determine when or where the safety mechanism was activated.Therefore, this complaint is inconclusive.Evaluation findings are in section h.11.

Event Description

It was reported that when opening the kit, the introducer needle with sheath did not have the sheath, and when the introducer needle was taken out of the case, the safety was locked and it could not be used.Reportedly, another kit was used to complete the procedure.There was no reported patient involvement.

• Brand Name: GROSHONG NXT CATHETER 5F BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 15032110
• MDR Text Key: 299070821
• Report Number: 3006260740-2022-02734
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 7957505J
• Device Lot Number: REFV2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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