MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE PNK 20GA X 1.88IN; INTRAVASCULAR CATHETER

Catalog Number	381237
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.1.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd insyte pnk 20ga x 1.88in had foreign matter.The following information was provided by the initial reporter translated from chinese to english: the customer of the hospital operating theatre opened the outer packaging of the product in the morning of 8.19, and after removing the protective cap, he found that there was dense black dirt on the needle tip hose (the actual recovered sample had already been partially wiped off by the customer's test), and on 8.21, the remaining 600 pcs.Of the batch of the product in the hospital were replaced according to the request of the equipment section.The head nurse was out for a meeting on the same day and agreed to retrieve the sample on 8.27.The hospital requested a note and stamp from the product.
Additional Manufacturer Narrative
2 photos were received for investigation (refer to attachment a).From the 2 photos, observed black foreign matter on the catheter tubing surface (refer to attachment a).Based on device history record review, no abnormality was observed during the production of the affected batch.As current control, there is an outgoing inspection and in-process 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).As no sample was received for further investigation, root cause could not be determined.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
The customer of the hospital operating theatre opened the outer packaging of the product in the morning of 8.19, and after removing the protective cap, he found that there was dense black dirt on the needle tip hose (the actual recovered sample had already been partially wiped off by the customer's test), and on 8.21, the remaining 600 pcs.Of the batch of the product in the hospital were replaced according to the request of the equipment section.The head nurse was out for a meeting on the same day and agreed to retrieve the sample on 8.27.The hospital requested a note and stamp from the product.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production run.Based on the evaluation on the returned sample, multiple spots of black, greasy fm were observed on the catheter tubing surface.The ftir results identified that the fm spectrum matches well with silicone.Based on the fm type, investigation was conducted on the potential fm sources.At the icam assembly machine, catheter lubricant, which is made of silicone, is applied via spraying onto the catheter.The lubrication will be homogeneously distributed on the catheter surface.However, the lubricant used is transparent in color, instead of black colour as observed on the returned sample.Hence, the silicone catheter lubricant from the icam assembly machine was unlikely the fm source.With no black silicone found in the components, or used in the machines, the actual fm source could not be identified.Actual root cause could not be established.Current control, there is an outgoing inspection and in-process 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).
Event or Problem Description
The customer of the hospital operating theatre opened the outer packaging of the product in the morning of 8.19, and after removing the protective cap, he found that there was dense black dirt on the needle tip hose (the actual recovered sample had already been partially wiped off by the customer's test), and on 8.21, the remaining 600 pcs.Of the batch of the product in the hospital were replaced according to the request of the equipment section.The head nurse was out for a meeting on the same day and agreed to retrieve the sample on 8.27.The hospital requested a note and stamp from the product.

• Brand Name: BD INSYTE PNK 20GA X 1.88IN
• Common Device Name: 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: 20212451
• Report Number: 2243072-2024-00966
• Device Sequence Number: 18093137
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370(10)4025728
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381237
• Device Lot Number: 4025728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 10/23/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/01/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown