MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL; INTRAVASCUALR CATHETER

Catalog Number	381223
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte¿, peripheral iv cannula, bd vialon¿ bio material the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: (b)(4) ¿ the catheter is peeling away from the needle every time.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 29-may-2023.H6: investigation summary: our quality engineer inspected the 1 photo and 10 samples, 1 was used and 9 were representative, submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the samples.Analysis of the samples showed that the 1 used sample had the needle through the catheter and blood stains were found in the needle hub.All the representative samples passed our inspection.Bd was unable to determine a manufacturing related root cause to the failure since the sample was returned in a used state and all representative samples passed the visual inspection.There is a possibility the defect reported could have occurred during use.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported while using bd insyte¿, peripheral iv cannula, bd vialon¿ bio material the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: the clinic reports 2 boxes of 50 of the instye 22x1 in blue (381223) ¿ the catheter is peeling away from the needle every time.

• Brand Name: BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL
• Common Device Name: INTRAVASCUALR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16842399
• Report Number: 8041187-2023-00184
• Device Sequence Number: 7508653
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 381223
• Device Lot Number: 2113089
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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