MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SL WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 7617405

Device Problems Break (1069); Fracture (1260); Material Rupture (1546); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redp1983 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that the catheter was placed in this patient on (b)(6) 2020.During maintenance on (b)(6) 2021, the external part of the catheter detached with the proximal end ruptured.X-ray indicated the internal part of the catheter fractured and the tip slipped towards the heart.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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a break in the catheter tubing was confirmed.One groshong 4fr single-lumen nxt picc was returned for investigation.The catheter exhibited evidence of use.Residue from use was observed throughout the catheter and the printing was worn from various parts of the catheter.The catheter tubing was received in two segments.The two-piece connector was attached and secured to the proximal catheter segment.The catheter tubing extended 7.4cm from the distal tip of the strain relief oversleeve.The distal end of the proximal catheter segment coincided with the 35cm depth mark.The distal catheter segment contained the black plug, 3-position valve, and was 31.5cm in length.The proximal end of the distal catheter segment coincided with the 30cm depth mark.The segment of tubing that contained the 31cm ¿ 34cm depth marks was not returned for investigation.A microscopic examination of the cross section near the 30cm depth mark revealed a granular surface.The external surface of the tubing exhibited superficial tears in the material approximately 0.5mm distal to the break site.A microscopic examination of the cross section near the 35cm depth mark revealed a granular surface.Semi-circumferential creases were observed in the tubing 7mm, 13mm, and 17mm proximal to the break site near the 35cm depth mark.The creases are consistent with repeated kinking of the catheter tubing.Kinking of the tubing and material fatigue may have been contributing factors of the reported break in the catheter.The picc was in use for more than 4 months before the catheter broke.Since the catheter was received in two segments, the complaint was confirmed; however, the exact mechanism of damage could not be determined.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the catheter was placed in this patient on (b)(6), 2020.During maintenance on (b)(6) 2021, the external part of the catheter detached with the proximal end ruptured.X-ray indicated the internal part of the catheter fractured and the tip slipped towards the heart.No other information was provided.

• Brand Name: GROSHONG NXT CLEARVUE 4F SL WITH SAFETY INTRODUCER
• 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
• MDR Report Key: 11369266
• MDR Text Key: 233246519
• Report Number: 3006260740-2021-00449
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7617405
• Device Catalogue Number: 7617405
• Device Lot Number: REDP1983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention