MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number 382434

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

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

Event Date 05/02/2022

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 while using bd angiocath plus¿ i.V.Catheter 20ga x 1.16in foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: user is unpackaged for use a catheter, but founded unkown black spot on needle.

Event Description

It was reported while using bd angiocath plus¿ i.V.Catheter 20ga x 1.16in foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: user is unpackaged for use a catheter, but founded "unknown" black spot on needle.

Manufacturer Narrative

H6: investigation summary: two photos and one sample with open packaging was received by our quality team for evaluation.From the photos, a black foreign matter was observed near the tip of the catheter, however, it could not be seen clearly.The top web packaging information was also provided in the photo.The sample was subjected to visual inspection.A loose, reddish brown and greasy foreign matter was observed near the tip of the catheter.The foreign matter was sent for fourier transform infrared spectroscopy (ftir) to determine the foreign matter type.The results indicated that the spectrum matches reasonably with silicone compound.Therefore, the foreign matter is likely to be of silicone material.The reddish brown and greasy foreign matter spectrum was compared with the tipping lubrication, catheter lubrication, and cannula lubrication spectrum.However, they were not an identical match due to a few unknown peaks detected from the reddish brown and greasy foreign matter.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.Based on the silicone foreign matter, an extensive investigation was conducted on the potential foreign matter sources ¿ material, machine, and man / environment.The two key components nearer to the foreign matter location were investigated: the catheter tubing where the foreign matter was located and the needle cover, as it may be transferred onto the catheter tubing during assembly.The catheter tubing is manufactured at bd sandy.During manufacturing, after the tubing leaves the extruder, it goes through the quench tank of water and then passes through an air blower to blow off the water before it is wound up on the drum.These processes would have removed the loose foreign matter.The device history review and production records of the affected batch were also reviewed, and no abnormalities were found.The needle cover was molded "in house" at bd tuas.The molding process is automated, except the packing of the molded parts into the polybags which is performed manually by production associates.After review of the returned sample, the team did not observe traces of reddish brown and greasy substances inside the needle cover, therefore needle cover is not the media of transporting the foreign matter to the catheter tubing.The entire manufacturing process was reviewed to identify the section of the process that has direct contact with the catheter tubing and the tube cutter machine, flaring station, tipping machine, and assembly machine were identified.There is no silicone applied on the catheter material at the tubing cutter machine or the flaring station, therefore this is not the source of the foreign matter.In the tipping process, only the catheter tip is in contact with the tipping lubrication.While the tipping lubrication is silicone, it is transparent not reddish brown in color.The foreign matter location also does not coincide with the lubrication area on the catheter.Therefore, the tipping machine is not the source.At the assembly machine, lubrication is homogeneously distributed on the catheter surface.Based on the returned samples, the foreign matter observed is in a lump at one specific location of the catheter, which is unlikely to be caused by the spraying.The lubrication used is also transparent not reddish brown.Therefore, the assembly machine is not the source.All machines on the production line are fully covered, the surfaces that are in contact with the product are cleaned periodically per the cleaning schedule.The white lint-free cloth that is used to clean the machine surfaces is poly (ethylene terephthalate) (pet) material, which does not match the foreign matter type.The personal protective equipment (ppe) used in the production area were looked into to identify those with similar characteristics of the foreign matter.The hair net, beard cover, and face mask are made of polypropylene.However, they are white in color and therefore, unlikely to be the foreign matter source.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD ANGIOCATH PLUS¿ I.V. CATHETER 20GA X 1.16IN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14547929
• MDR Text Key: 293148169
• Report Number: 8041187-2022-00270
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382434
• Device Lot Number: 1230280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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