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

Catalog Number	381237
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in silicone visible insyte indwelling needles (381237) were found to have a rough tip and silicone oil lumps were pushed out of the catheter on pre-use inspection.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Catheter tip damaged: from the returned actual sample, damaged catheter tip was observed.The assembly process was reviewed.If the catheter tip damage occurred during the manufacturing process, the defect would have been detected and automatically rejected by the 100% inline vision inspection system, due to not meeting the lie distance requirement.Catheter tip damage could happen during product application when the product was manipulated.As the sample was returned in opened package, actual root cause could not be established.As current controls, there are outgoing and in-process visual inspections in place to check for catheter tip damage.Silicone visible from the returned actual sample, observed gel-like substance on the catheter tubing.Clear, gel-like liquid substance was observed on the catheter mid-section.The liquid substance is most likely a result of excessive lubricant deposit on the catheter.The excessive lubricant most likely occurs during catheter tipping process, when additional lube was applied to the catheter tip during the set up.Given the gel-like nature of the lube, it was possible for the excessive lube could flow from the tip and deposit on the catheter mid-section depending on the product storage position.As the actual sample was returned in open packaging, the actual root cause was unable to be established.As current control, there is an outgoing visual inspection in place to check for excessive lubricant on catheter.The following action had been implemented on 31 mar 2024 to address the possible root cause i.Conduct complaint awareness training and communication to all insyte tipper and icam production technicians (pts), to monitor the occurrence of the excessive lube defect.
Event or Problem Description
Insyte indwelling needles (381237) were found to have a rough tip and silicone oil lumps were pushed out of the catheter on pre-use inspection.

• 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: 19893170
• Report Number: 2243072-2024-00847
• Device Sequence Number: 7628551
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370(11)240201(17)290131(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
• Report Date (Section B): 10/02/2024

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: Other
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown