MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD INSYTE GRAY 16GA X 1.77IN; INTRAVASCULAR CATHETER

Catalog Number	381257
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3.Franklin lakes has been listed as the manufacturer.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 insyte gray 16ga x 1.77in tubing was defective/damaged.The following information was provided by the initial reporter: "during use, vialon tube broken".
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From returned sample, observed needle pierced through catheter or a ¿v-cut¿ on the catheter that matches the shape of the bevel, which could be caused by needle pierced through catheter.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needle pierced through catheter could happen during product application when the product was manipulated, or during needle cover removal.As current control, there is outgoing inspection and hourly in-process inspection in place to check for needle pierced through catheter.As the returned sample was used, actual root cause could not be established.
Event or Problem Description
During use, vialon tube broken.

• Brand Name: BD INSYTE GRAY 16GA X 1.77IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19353751
• Report Number: 2243072-2024-00636
• Device Sequence Number: 7510046
• Product Code: FOZ
• UDI-Device Identifier: 00382903812578
• UDI-Public: (01)00382903812578
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151698
• 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): 07/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 381257
• Device Lot Number: 1274727
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown