MAUDE Adverse Event Report: BECTON DICKINSON BD ANGIOCATH PLUS 22GA X 1IN; INTRAVASCULAR CATHETER

Catalog Number 382423

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

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd angiocath plus 22ga x 1in had foreign matter foreign material in catheter.

Event Description

Foreign material in catheter.

Manufacturer Narrative

Based on device history record review, no abnormality was observed during the production run.In-process inspection record and outgoing inspection record had showed no foreign matter detected on the catheter.No quality notification was raised for similar nonconformance during the production of this batch.From the returned sample, a tiny speck of black particle foreign matter (fm) embedded in transparent gel was observed near the tip of the catheter, which was much smaller in size compared to that of returned photo.Hence, it was suspected that the fm might have broken off during handling or transportation of the sample.The transparent gel around the black fm was highly likely the catheter lubricant based on the transparent colour and sticky gel-like texture.Based on the ftir results, the fm spectrum matches reasonably with that of silicone.Based on the silicone fm type, an extensive investigation was conducted on the potential fm sources ¿ material, machine and man/environment.1) material: the two key components nearer to the fm location were investigated.The catheter tubing was where the fm was located at, and for the needle cover, if there is fm in the needle cover, it might get transferred onto the catheter tubing during assembly.¿ catheter tubing was purchased from our bd sister plant in sandy, usa.The catheter tubing is made of polyurethane material.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 fm if it existed.The dhr and production records of the affected batch was also reviewed, and no abnormality was found.¿ needle cover was molded inhouse in tuas plant.The needle cover is made of polypropylene material.The molding process is automated, except that packing of the molded parts into the polybags is performed manually by production associates.Review of the returned sample did not observe traces of black substance inside the needle cover, therefore needle cover is unlikely the media of transporting the fm to the catheter tubing.2) machine: the entire manufacturing process was reviewed to identify the section of the process that has direct contact with the catheter tubing.¿ at the tube cutter machine, the catheter in the spool form is cut into the pieces and then transferred to the tubing tray.At the tube cutter machine, there is no silicone applied on catheter material.Reviewed the entire machine and there were no red material/substances at the area.Hence, tube cutter machine is not the source of the fm.¿ at the flaring station of the isam machine, the catheter is in contact with two rubber pads, which hold onto the tubing and move it downwards to assemble to the metal wedge (refer to figure 5 in attachment b for the set up at flaring station, and figure 6 in attachment b for the rubber pad).Based on the material specification provided by the rubber pad supplier, the rubber pads are made of neoprene rubber (polychloroprene), which does not match with the fm type.There is also no silicone applied on the catheter material.Hence, the flaring station is unlikely the fm source.Figure 5: flaring station.Figure 6: black rubber pad.¿ at the tipping machine, the catheter is pre-cut to required length, form of the required catheter tip and then load to the catheter tipper pallet.In this tipping process, only the catheter tip is in contact with the tipping lubrication.The tipping lubricant is silicone; however, the silicone is transparent in color not black in colour.The foreign matter location also does not coincide with the lubrication area on the catheter.Hence, tipping machine is not the source of the fm.¿ at the icam assembly machine, catheter lubricant (refer to figure 7 in attachment b) which is silicone is applied via spraying onto the catheter.The lubricant will be homogeneously distributed on the catheter surface.Based on the returned samples, the foreign matter observed is inside a lump of lubricant at one specific location of the catheter, which is unlikely cause by the spraying.The lubricant used is also transparent in color, not black in colour.Hence, icam assembly machine is not the source of the fm.Figure 7: matching sample sent for ftir analysis ¿ catheter lubricant.¿ all the machines on the production line are fully covered, surfaces that are in contact with product are cleaned periodically per the cleaning schedule.The white lint-free cloth that is used to clean the machine surfaces is made of poly(ethylene terephthalate) (pet) material, which does not match with the fm appearance and type.3) man/environment: the personal protective equipment (ppe) used in the production area were looked into to identify those with similar characteristics of the fms.¿ there is no ppe to be found with similar colour of the fm.The hair net, beard cover and face mask are white in colour while the cleanroom smock was dark blue in colour.¿ hence, the man/environment is unlikely the fm source.The fm was identified to be silicone compound but black in colour.The tipping, catheter and cannula lubricant used in the manufacturing lines were transparent in colour and ftir results indicated the catheter lubricant was an identical match with the fm.However, the colour of the fm did not match with the transparent catheter lubricant used.The entire manufacturing line was reviewed and there were no black silicone material/substances used at the tube cutter, isam sub-assembly, tipping and icam assembly machines.The source in manufacturing could not be identified.Actual root cause could not be established.With no black silicone material found on the components, or used in the machines and man/environment, the actual foreign matter source could not be identified.As this is the first reported fm complaint for this batch, this is most likely an isolated case.As current controls, there are outgoing and hourly in-process visual inspection in place to check for foreign matter.There is also a 4-hourly housekeeping in place to clean all the machine mechanisms in direct contact with products with alcohol (70% ipa).

• Brand Name: BD ANGIOCATH PLUS 22GA X 1IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18839469
• MDR Text Key: 337468517
• Report Number: 2243072-2024-00252
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: 382423
• Device Lot Number: 3296016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1