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

Model Number	303369
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd threaded lock cannula was broken, but still operable.The following information was provided by the initial reporter: "before use, it was unable to insert the cannula into a syringe.".
Additional Manufacturer Narrative
H.6.Investigation: three photos were received and evaluated.The photos depicted a single threaded lock piece connected to a 3ml syringe and transfer tubing.What appeared to be fluid was observed inside the threaded lock.A close-up photo of the piece showed it had short cannula defect.No cavity nor batch information was provided.One used physical sample received for evaluation, upon inspection of the returned units it was found that the unit has a short cannula.It was also found that the unit was from cavity 43.A short cannula may occur due to the core pin being pulled back into the part during the molding process.The units were received with the interlink connecter connected to a needle injection site.The interlink will not pierce through the needle injection site as a needle is required to perform that function.The syringe and the interlink function as intended on the female luer side when the needle injection site is disconnected.A short cannula occurs when the core pin is too hot causing it to pull the cannula as the core pin is retracted at the end of the molding cycle and prior to ejection.This condition does not pass the leak test.Preventative maintenance is also performed to prevent buildup inside the cooling channels.Buildup may affect the cooling of the core pin resulting in a short cannula.
Event or Problem Description
It was reported that bd threaded lock cannula was broken, but still operable.The following information was provided by the initial reporter: "before use, it was unable to insert the cannula into a syringe.".

• Brand Name: BD THREADED 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: 10394152
• Report Number: 1213809-2020-00523
• Device Sequence Number: 14187490
• Product Code: FMI
• UDI-Device Identifier: 30382903033691
• UDI-Public: 30382903033691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011858
• Number of Events Summarized: 1
• Summary Report (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): 09/24/2020

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: 303369
• Device Catalogue Number: 303369
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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