MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 26 of the bd insyte¿ iv catheter needle through catheter.The following information was provided by the initial reporter: catheter out of needle.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 26 of the bd insyte¿ iv catheter needle through catheter.The following information was provided by the initial reporter: catheter out of needle.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 5 photos submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the photo, but the photos were too zoomed out to confirm the defects of needle penetration difficult / painful and needle dull / blunt.Bd cannot confirm the causes of the failures to our manufacturing process since no sample was returned for evaluation.Device history record of packaged needle (pn) batch 2234328 ,catalogue number 381223 and its assembled needle (an) batch 2237726, part number yf01212sgt was reviewed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From all the returned samples, 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 samples were used or returned in open or without packaging, actual root cause could not be established.All the returned samples exclude the contaminated sample passed the visual inspection with no cannula tip damage and cannula penetration forces within the specifications.Current control there is an outgoing inspection and 1 hourly in-process inspection in place to check for cannula tip hooked or point damage.There is also a daily outgoing functional test in place to check for cannula penetration force.
Event or Problem Description
Catheter out of needle, the needle is not sharp, hard to puncture.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17760664
• Report Number: 8041187-2023-00491
• Device Sequence Number: 12425678
• Product Code: FOZ
• UDI-Device Identifier: 30382903812128
• UDI-Public: (01)30382903812128
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: Other
• Device Catalogue Number: 381212
• Device Lot Number: 2234328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/10/2023; 11/07/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/19/2023; 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown