MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ I.V. CATHETER 24GA X 0.75IN (0.7 X 19 MM) (VIALON E); INTRAVASCULAR CATHETER

Catalog Number 388412

Device Problem Fracture (1260)

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

Event Date 07/02/2021

Event Type  malfunction  

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 Description

It was reported that bd insyte¿ i.V.Catheter 24ga x 0.75in (0.7 x 19 mm) (vialon e) contained foreign matter.The following information was provided by the initial reporter: " according to the customer's report, the hcp found a dirt on the needle tip before venipuncture.".

Event Description

It was reported that bd insyte¿ i.V.Catheter 24ga x 0.75in (0.7 x 19 mm) (vialon e) contained foreign matter.The following information was provided by the initial reporter: " according to the customer's report, the hcp found a dirt on the needle tip before venipuncture.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-08-10 h6: investigation summary eight photos and twenty-seven samples, one actual and twenty-six representative samples, were received by our quality team for evaluation.The photos and samples were subjected to visual inspection to check for foreign matter.A piece of white, loose, paper-like foreign matter was observed on the catheter tubing.On the representative samples, no foreign matter was observed.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 foreign matter was sent for fourier transform infrared spectroscopy (ftir) analysis to determine the foreign matter type.The results indicate that the spectrum matches reasonably with that of cellulose, ethylene vinyl acetate and amide-based compounds.An investigation was conducted to identify the potential foreign matter sources.All the personal protective equipment (ppe) and production materials used in the production area were looked into to identify those with similar characteristics of the foreign matter.The top web paper, hand towel, and dispenser label were found to have similar appearance (white paper-like, could be torn into small pieces) with the foreign matter.Based on the ftir analysis, the middle layer of the dispenser label had the highest matching percentage with the foreign matter sample.Dispenser labels are used in the secondary packaging line, where the blank labels get printed with the product and batch information before being pasted onto the dispenser cartons that are filled with the unit-packaged products.As the secondary packaging line is located in a different area from the cleanroom where the main assembly was carried out, there is an extremely low possibility for pieces of the dispenser label to travel to the main assembly line, into the covered machine and landed on the catheter tubing.It is highly unlikely that the introduction of the foreign matter occurred during the secondary packaging process, as the product will have already been capped with the needle cover and packaged in the unit packaging.The manufacturing process was reviewed.All the machines on the production line are fully covered and surfaces that are in contact with the product are cleaned periodically per the cleaning schedule.Also, the manufacturing process is automated, with minimal human intervention.As the sample was returned in open packaging, the root cause was unable to be established.This defect could happen outside of the tuas manufacturing facility.This foreign matter case is most likely an isolated case.Based on the complaint history review, this is the first foreign matter incident reported for this batch, and no complaint of similar foreign matter appearance was reported in the past six months.

• Brand Name: BD INSYTE¿ I.V. CATHETER 24GA X 0.75IN (0.7 X 19 MM) (VIALON E)
• 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: 12364750
• MDR Text Key: 268036675
• Report Number: 8041187-2021-00767
• 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,Followup
• Report Date: 10/04/2021

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
• Device Operator: Other
• Device Catalogue Number: 388412
• Device Lot Number: 0268580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 12/04/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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