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

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redv2886 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the package of the product was found unsealed prior to use.No other information was provided.

Event Description

It was reported that the package of the product was found unsealed prior to use.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 that the packaging was unsealed before use was inconclusive due to the sample condition.One groshong nxt clearvue catheter kit was returned for investigation.The outer packaging with the label was returned with various components from the kit.The outer packaging had been opened.The tyvek flap remained attached to the top edge of the pouch.Evidence of a complete seal was observed where the tyvek had been peeled away from the pouch.A white colored band that was 12.5mm to 14mm in width was observed along the edge of the pouch where material was transferred from the tyvek flap.No gaps were noted in the material transfer along the edge of the pouch.No other damage was observed on the tyvek or pouch.The inner tray was not returned for investigation, but two photographs that were provided for investigation showed the inner tray within the outer packaging.The tyvek appeared to be partially removed from the inner tray.A tactual investigation revealed that the remainder of the seal was intact and the tyvek was adhered to the bag.The packaging exhibits evidence that it was properly sealed, but may have been inadvertently opened outside bd control.Potential contributing factors of the reported damage include handling or storage conditions; however, the exact cause of the complaint could not be determined.

• Brand Name: GROSHONG NXT CLEARVUE 4F SL BT W/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: 13023093
• MDR Text Key: 282393824
• Report Number: 3006260740-2021-05351
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• 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

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: REDV2886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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