MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr2319 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when the catheter was flushed after connecting the catheter and the oversleeve, leakage was found near the oversleeve.When the new catheter connector was connected to the catheter, no leakage was found.There was no reported patient injury.

Event Description

It was reported that when the catheter was flushed after connecting the catheter and the oversleeve, leakage was found near the oversleeve.When the new catheter connector was connected to the catheter, no leakage was found.There was no reported patient injury.

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 confirmed is confirmed.One 4 fr single lumen groshong nxt clearvue catheter was returned for evaluation.An initial visual observation showed a small amount of use residue on the returned sample.The returned sample was flushed and pressurized, and a leak was observed in the catheter emanating from within the assembled two-piece connector.The two-piece connector was unassembled, and a microscopic observation revealed a relatively large, diagonal split in the catheter just distal to the metal cannula of the proximal connector piece the catheter was assembled onto.The outer edges of the split were observed to be jagged with a distinct and consistent pattern.The fracture surfaces were observed to be uneven but granular in texture.The shape and texture of the split observed in the returned sample indicate the catheter was most-likely damaged due to contact with a metallic instrument such as hemostats or another hard, textured surface.H3 other text : evaluation findings are in section h.11.

• Brand Name: GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13117758
• MDR Text Key: 282965806
• Report Number: 3006260740-2021-05479
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034020
• 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: 02/24/2022

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: N/A
• Device Catalogue Number: 7617405J
• Device Lot Number: REFR2319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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