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

Model Number	381334
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte-w¿ iv catheter experienced the needle piercing through the catheter.The following information was provided by the initial reporter: the nurse noticed that when unlocking the catheter and removing the mandrel, the body of the catheter inserted into the patient's vein bent, rendering the device unusable.Clinical consequences and current status of the patient or affected person : loss of time and impact on the organization of the service.Risk of patient injury actions taken for the patient or person involved loss of time and impact on the organization of the service.Risk of injury to the patient.
Additional Manufacturer Narrative
Investigation summary: one sample was received by our quality team for evaluation.The sample was subjected to visual inspection.From the sample, the needle was observed to be pierced through the catheter near the tip.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.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 inline tip spear vision inspection system.Needle pierced through catheter could also happened during product application when the product was manipulated or during the needle cover removal if not done carefully.The following controls have been put in place to prevent and detect the needle being pierced through catheter from occurring: the vision system camera is not out of focus when capturing the defect by using various metal blocks for different gauges to prevent the vision assembly from dropping under its weight and the catheter is aligned to one side using vacuum to aid the insertion of the cannula thus reducing the likelihood of this nonconformance from occurring.A daily challenge of the vision system is performed, and visual inspection is performed during outgoing inspection.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned photos and sample, observed needle pierced through catheter near the tip area.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 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 if not done carefully.Control is in place to prevent and detect needle pierced catheter in which improvements were made as per capa# (b)(4).Vision system camera is not out of focus when capturing the defect by using various metal block for different gages to prevent the vision assembly from dropping under its own weight.Catheter was aligned to one side using vacuum to aid the insertion of the cannula thus reducing the likelihood of pierce through etc.Daily challenge of the vision system was performed as per insyte operation daily process/ hse keeping (icam), mfg-008/bc visual inspection is performed during outgoing inspection as per test specification insyte assemble needle: visual inspection 80006088.

• Brand Name: BD INSYTE-W¿ IV CATHETER
• Common Device Name: INTERVASCULAR 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: 13211781
• Report Number: 8041187-2022-00001
• Device Sequence Number: 19254145
• Product Code: FOZ
• UDI-Device Identifier: 30382903813347
• UDI-Public: 30382903813347
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 01/10/2022

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 Expiration Date: 07/31/2026
• Device Model Number: 381334
• Device Catalogue Number: 381334
• Device Lot Number: 1203309
• 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: 01/07/2022
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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