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

Model Number	381311
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd insyte-n¿ iv catheters the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: during the preparation of the pkv, a defective plastic cannula was detected on 3 pvks.This is indicated by a slight change / thickening on the plastic cannula.If the needle is briefly withdrawn outside the patient and then carefully advanced again, the plastic cannula may be punctured with the needle in the area of the thickening.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-mar-2023.Investigation summary: our quality engineer inspected the 2 photos and 3 samples submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the sample photos and samples.Analysis of the sample photos showed that the needle of the device was through the catheter near the tip area.All 3 samples were examined.One sample had a ¿v¿ cut in the catheter tubing near the tip, one sample had the needle through the catheter near the tip and the final sample did not have any damages to the catheter.Bd was unable to determine a root cause for the reported defect since the samples with the catheter damages were returned in a used state.The ¿v¿ cut observed on one of the samples could be occur during product application or needle cover removal, but these root causes cannot be confirmed.There are currently controls in place during manufacturing that would automatically reject products with needle through catheter damages.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported while using bd insyte-n¿ iv catheters the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: during the preparation of the pkv, a defective plastic cannula was detected on 3 pvks.This is indicated by a slight change / thickening on the plastic cannula.If the needle is briefly withdrawn outside the patient and then carefully advanced again, the plastic cannula may be punctured with the needle in the area of the thickening.

• Brand Name: BD INSYTE-N¿ IV CATHETERS
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16301888
• Report Number: 8041187-2023-00049
• Device Sequence Number: 6185458
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: (01)30382903813118
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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 Model Number: 381311
• Device Catalogue Number: 381311
• Device Lot Number: 2021235
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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