MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IAG BC PRO GLOBAL GRN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number 381044

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

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received five sealed units and three photos.Upon visual inspection, a black foreign material was found on the inside of the needle cover loose inside of one of the sealed units.Your reported defect was confirmed.As the device was sealed, the defect of foreign matter can be attributed to the manufacturing or packaging process.Operators perform good manufacturing practices and gowning per the quality plan, as well as, periodic inspection for foreign matter per the sampling plan.A device history record review showed no non-conformance's associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.

Event Description

It was reported when using the iag bc pro global grn 18ga x 1.16in, the device experienced foreign matter visible on noninvasive components of needle (hub, needle shield , packaging).The following information was provided by the initial reporter.The customer stated: the customer reported about a black spot (fm) found on the product.

• Brand Name: IAG BC PRO GLOBAL GRN 18GA X 1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12556585
• MDR Text Key: 274745375
• Report Number: 1710034-2021-00853
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/30/2021

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: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 381044
• Device Lot Number: 0322452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• 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