MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 382412

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

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

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd angiocath iv catheter had foreign matter on the needle tip.The following information was provided by the client: "foreign material in the catheter tube".

Event Description

It was reported that the bd angiocath iv catheter had foreign matter on the needle tip.The following information was provided by the client: "foreign material in the catheter tube.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 03-mar-2022.H.6.Investigation: one photo and one sample with open packaging were received by our quality team for evaluation.The photo was subjected to visual inspection to check for foreign matter.A piece of black foreign matter was observed on the catheter tubing.There was also a brownish mark on the catheter tubing.The sample was subjected to visual inspection.A piece of brownish, black, loose foreign matter was observed on the catheter tubing, approximately 3 mm from the catheter tip.There was also a brownish embedded mark on the catheter tubing, around 7mm from the catheter tip.The size of the foreign matter was approximately 1mm squared.The foreign matter sample was sent for fourier transform infrared spectroscopy (ftir) analysis to determine the foreign matter type.The ftir results indicate that the best match is polystyrene.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 polystyrene foreign matter type, an extensive investigation was conducted on the potential foreign matter sources ¿ material, machine, and man / environment.It was found that there is another product using polystyrene as the molding resin for two of its components.Burnt resin, from the start-up purging process, was found near the molding lines.The burnt resin is highly matching with the foreign matter in appearance and texture.The ftir analysis showed a high matching percentage with the complaint foreign matter as well.Therefore, the burnt resin could be a potential foreign matter source.The foreign matter introduction route was suspected to be through the manual packaging process at the molding lines.Upon further review of the dhr of the molded components, it was found that both molding lines of the angiocath plus and the other product were run by the same group of production associates during the production dates of the affected batch.Therefore, it is possible that the burn resin was transferred from the other product molding line to the angiocath plus needle cover during the packaging process, if the associate did not change to new gloves before handling.In summary, as no polystyrene-based material was found near the angiocath plus manufacturing lines, the actual foreign matter source could not be confirmed.A potential foreign matter source could be that the burnt molding resin that was used in another product, as the molding machine was situated in the same production area as the angiocath plus manufacturing lines.The loose foreign matter could possibly be introduced into the needle cover through contaminated gloves during the material packing process at the molding lines, and then subsequently onto the catheter tubing during the needle cover assembly process at the final assembly line.

• Brand Name: BD ANGIOCATH IV CATHETER
• Type of Device: 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: 13698142
• MDR Text Key: 287025704
• Report Number: 8041187-2022-00112
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382412
• Device Lot Number: 1274833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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