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	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in had foreign matter the customer reported that there was a jelly-like viscous unknown substance in the indwelling needle and asked the company to inspect it.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Based on the ftir results, the foreign matter spectrum matches reasonably with that of silicone.Based on the fm material type, investigation was conducted to identify the potential fm sources.From the sticky, gel-like properties of the fm, and given the fm material type was silicone, it was suspected that the fm was the silicone lube applied on the catheter and cannula surfaces of the product to aid lubrication during product insertion.As the fm appearance was droplet-like, it was suspected that it was due to excessive lube on the catheter surface that aggregated and formed a droplet-like lump on the catheter surface.Given the gel-like nature of the lube, it was possible for the lube to flow to different locations on the catheter during transportation or storage.It was possible that during needle cover removal, when the product was maneuvered, the lube lump that was formed on the catheter touched the needle cover inner wall and sticked there.As the sample was returned in open packaging, the actual root cause was unable to be established.
Event or Problem Description
The customer reported that there was a jelly-like viscous unknown substance in the indwelling needle and asked the company to inspect it.

• 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: 19420765
• Report Number: 2243072-2024-00660
• Device Sequence Number: 8029952
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 3279822
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown