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

Catalog Number	303370
Medical Device Problem Codes	Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found before use with a bd lever lock cannula.The following information was provided by the initial reporter, "per email: one of the nurses approached me with a bd level lock cannula.(on the division, the nurses refer to it as a "yellow alligator clamp/clip.") - ,i got a good look at it and i was appalled and concerned.I immediately looked at the lot number on the item in question and started pulling them from our med rooms that share the same lot number.Since i pulled all of the yellow clamps with the lot number in question, it left us with very few on our floor.At that point, i decided to order 2 boxes for the floor before i left for the night.(~2:30am).Shortly after i had left the building, a gentlemen from the general stores called and said he only has boxes of the same contaminated lot available downstairs for the distribution.A nurse informed him that they are not interested in having that lot number for that item on our floor at this time until further notice.I really wanted to get this information out to everyone especially since i have no idea what is going on with that clamp and the lot in general- mold? blood?-obviously the clamp is contaminated.Also, from what i could tell the packaging was fully intact.It was not opened.The one that was found is currently on a desk in a bio hazard bag.".
Event or Problem Description
It was reported that foreign matter was found before use with a bd lever lock cannula.The following information was provided by the initial reporter, "per email: one of the nurses approached me with a bd level lock cannula.(on the division, the nurses refer to it as a "yellow alligator clamp/clip.") - ,i got a good look at it and i was appalled and concerned.I immediately looked at the lot number on the item in question and started pulling them from our med rooms that share the same lot number.Since i pulled all of the yellow clamps with the lot number in question, it left us with very few on our floor.At that point, i decided to order 2 boxes for the floor before i left for the night.(~2:30am) shortly after i had left the building, a gentlemen from the general stores called and said he only has boxes of the same contaminated lot available downstairs for the distribution.A nurse informed him that they are not interested in having that lot number for that item on our floor at this time until further notice.I really wanted to get this information out to everyone especially since i have no idea what is going on with that clamp and the lot in general- mold? blood?-obviously the clamp is contaminated.Also, from what i could tell the packaging was fully intact.It was not opened.The one that was found is currently on a desk in a bio hazard bag.".
Additional Manufacturer Narrative
Investigation: four photos of an interlink cannula in a fully sealed blister pack confirmed to be from batch 8001589 (p/n 303370) were received and evaluated.It was observed there was reddish embedded foreign matter particles throughout the interlink but mostly on one of the wings.They appeared to be burnt plastic with some particles larger than level 3 in size, which were rejectable per product specification.The mold number could not be determined from the photos.The embedded fm is most likely degraded plastic and appears red due to the yellow dye in the resin.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.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded fm 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.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.

• Brand Name: BD LEVER LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8735889
• Report Number: 1213809-2019-00663
• Device Sequence Number: 11095347
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K940697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 303370
• Device Lot Number: 8001589
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other