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

Catalog Number 388411

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

It was reported that transparent, liquid-like foreign matter was found in 2 bd insyte¿ iv catheters.The following information was provided by the initial reporter, translated from japanese to english: "the customer reported that the catheter was damaged before use." via bd investigation: "from the photos, the first sample was observed to have a cut and a visible lump of transparent, liquid-like substance near the catheter tip.".

Manufacturer Narrative

Investigation summary: eight photos and two samples were received by our quality team for evaluation.From the photos, the first sample was observed to have a cut and a visible lump of transparent, liquid-like substance near the catheter tip.The second sample was observed a slanted cut on the catheter tubing.The samples were subjected to visual inspection.The first sample was observed with a ¿v-cut¿ near the catheter tip.The second sample was observed with a long, slanted cut on the middle section of the catheter tubing.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 ¿v-cut¿ on the catheter matches the shape of the bevel, which could be caused by the needle pierced through the 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 also happened during product application when the product was manipulated.There is no station in the assembly process that will cause the observed long, slanted cut.This could also happen during product application when the product was manipulated.As the samples were returned without packaging, the root cause could not be established.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 nonperformance 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.

• Brand Name: BD INSYTE¿ IV CATHETER
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12807807
• MDR Text Key: 281856369
• Report Number: 8041187-2021-00972
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388411
• Device Lot Number: 0208816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1