MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS CANNULA INTERLINK LEVER LOCK; INTRAVASCULAR ADMINISTRATION SET

Model Number	303370
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: the customer provided lot # 9062739.This does not match the catalog number provided.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that cannula interlink lever lock had foreign matter.The following information was provided by the initial reporter: product contamination.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received and evaluated.The photo showed a top web view of a single package, confirmed to be from batch #9052739 (p/n 303370).No cannula product was seen in the photo.The reported defect was not observed in the photo provided.Three additional photos were received and evaluated.The photos depicted an opened lever lock package with the shielded cannula inside.The lever lock body had numerous dark foreign matter particles throughout.The foreign matter appeared to be embedded in the product.Additionally, one loose lever lock samples was received and visually evaluated.The numerous dark foreign matter particles were observed throughout the sample.The particles were embedded.Potential root cause for the embedded foreign matter defect is associated with the molding handling process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Per procedure, after start up, all molded parts are scrapped until no degraded plastic is observed.If this is not performed thoroughly a piece with this condition can get through.This type of defect is cosmetic and does not pose risk to the customer.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that cannula interlink lever lock had foreign matter.The following information was provided by the initial reporter: product contamination.

• Brand Name: CANNULA INTERLINK LEVER LOCK
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11168169
• Report Number: 1213809-2021-00016
• Device Sequence Number: 3637333
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K940697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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 Model Number: 303370
• Device Catalogue Number: 303370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1