MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds0101 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the inside of the packaging box for the catheter affected was stained with ink from the text printed on the pouch.In addition, there was black dust on the white pouch of the catheter.The device was not used on a patient.

Event Description

It was reported that the inside of the packaging box for the catheter affected was stained with ink from the text printed on the pouch.In addition, there was black dust on the white pouch of the catheter.The device was not used on a patient.

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, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material in the device packaging was inconclusive due to poor sample condition.One opened 4 fr groshong nxt catheter kit was provided for evaluation.The kit product label indicted lot: reds0101.The outer tyvek lid was opened in order to inspect the inner tray containing the kit components.The catheter with the internal stiffening stylet was present within the tray along with a sealed statlock pouch.No black dust was observed in the tray.The statlock pouch was removed from the tray and no adhesion to the tray was noted.Microscopic of the inner and outer tray did not reveal any evidence of ink transfer from the statlock pouch.The print on the outer statlock pouch did not appear to have missing ink material.A spec of loose material was present within the opened inner tray.The spec appeared to have a light-brown color and appeared fibrous in nature.It is unknown if the light-brown particle was introduced into tray after package opening.The event description indicates that the tray was stained with ink from the printed pouch.The ink transfer on the kit tray may have appeared to be dark particles; however, as no evidence of ink material transfer was noted, the complaint could not be confirmed and remains inconclusive at this time.Although the complaint could not be confirmed from the sample provided, possible contributing factors to statlock pouch ink transfer include environmental storage conditions.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10620566
• MDR Text Key: 209603139
• Report Number: 3006260740-2020-03431
• 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
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REDS0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1