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

Catalog Number	381237
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in had foreign matter.The outpatient operating room reported that upon opening the outer packaging, it was found that there was a black foreign body inside the catheter.The affected quantity was 1 catheter.The sample can be returned.Photographs can be provided.A green claim settlement is required, as well as a complaint response letter and a complaint acceptance letter.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Our quality engineer inspected the photo, and sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed black greasy foreign matter on the cannula, catheter, and needle cover.Fourier transform infrared spectroscopy (ftir) analysis was performed to determine the foreign matter type.It was determined that it matches well with silicone.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Based on the foreign matter type, an investigation was conducted on the potential sources.At the assembly machine, lubricant which is made of silicone is applied onto the cannula and catheter.The lubricant used is transparent in color, instead of black as observed on the returned sample.There is no other black silicone source in the machine.With no black silicone found in the components, or used in the machines, the actual foreign matter source could not be identified.As this is the first reported foreign matter complaint for the lot, it is most likely an isolated case.Current controls include outgoing and in-process visual inspections to check for foreign matter.Additionally, there is a 4-hourly housekeeping schedule to clean all machine mechanisms in direct contact with products using 70% ipa alcohol.

• 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: 21200247
• Report Number: 2243072-2025-00006
• Device Sequence Number: 7504052
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370(11)240803(17)290731(10)4207247
• 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
• Report Date (Section B): 02/21/2025

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: 4207247
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown