MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 18G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Contamination /Decontamination Problem (2895)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

It was reported by the customer that when they opened the product, it was evident the content inside was not sterile.Additional information provided 16 oct 2023 this product was opened and visible soiled.This was not used on any patient.No life threatening situation, or delayed medication or care.

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.

Event Description

It was reported by the customer that when they opened the product, it was evident the content inside was not sterile.Additional information provided 16 oct 2023 : this product was opened and visible soiled.This was not used on any patient.No life threatening situation, or delayed medication or care.

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.Based on a review of this information, the following was concluded: the complaint of contaminates on a statlock pro is confirmed, but the exact cause could not be determined.One 18 ga powerglide pro, one statlock pro, one skin prep pad and its packaging was returned for evaluation.An initial visual observation revealed the statlock pro had an orange/red residue on the foam pad near the plastic portion where the catheter attaches.No other use residues were observed throughout the powerglide pro or the packaging.The product was returned opened.A microscopic observation revealed the residues observed on the statlock device to only be on the right wing beside the plastic portion of the device.The residue appeared to be soaked into the pad of the device.Because the devices were returned opened, the complaint of contaminates on a statlock pro is confirmed, but the exact cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: BASIC KIT 18G X 8 CM WITH BIOPATCH
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18006021
• MDR Text Key: 326709564
• Report Number: 3006260740-2023-04824
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140501
• UDI-Public: (01)00801741140501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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: F318087T
• Device Lot Number: REHU1856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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