MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL PNK 20GA X 1.0IN; PERIPHERAL IV CATHETERS

Catalog Number	381033
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd iag bc pro global pnk 20ga x 1.0in had leakage at the catheter junction.The following information was provided by the initial reporter translated from japanese to english: this is a complaint about leaking from catheter joint.It was reported that when the catheter was punctured, blood flowed backward, leakage occurred from the joint.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photographs and sample submitted for evaluation.Bd received three photographs and one 20g insyte autoguard bc pro iv catheter.The returned sample matched the iv catheter in the photographs.The sample exhibited evidence of use.The iv catheter was received without the needle and what appeared to be blood residue was observed within the catheter tubing and adapter.As it was reported that the adapter was leaking, the returned unit was tested for leakage.Leakage was confirmed from the midpoint of the pink catheter adapter.A microscopic examination revealed a crack in the adapter over the wedge.The crack appeared to follow the knit line from the molded adapter and was located opposite from the gate mark.The adapter was separated, and the outside diameter of the wedge was measured and found to be within the specification.The observed damage likely occurred during the manufacturing process in the assembly process.Per the quality plan, inspections for damaged adapter/catheter tubing are performed periodically during the manufacturing process to mitigate the occurrence of this defect.A device history record review could not be performed as the lot number is unknown.
Event or Problem Description
No additional information.

• Brand Name: BD IAG BC PRO GLOBAL PNK 20GA X 1.0IN
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19801737
• Report Number: 1710034-2024-00754
• Device Sequence Number: 7496857
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: (01)00382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown