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

Model Number	303369
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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.
Event or Problem Description
It was reported that bd threaded lock cannula had a connector defect.This occurred on 2 occasions during use.The following information was provided by the initial reporter: 2 threaded locks turned and never stopped.Also hcp couldn't inject to another threaded lock.
Additional Manufacturer Narrative
H.6.Investigation: multiple photos were received and evaluated.Samples could not be returned to the manufacturing site due to the global pandemic.Two threaded lock pieces from cavities 42 and 18 were observed with damage to their luer ¿ears.¿ one threaded lock piece from cavity 43 was observed to have a short cannula condition.Potential root cause for short cannula is associated with the defective material from supplier.Short cannula defect was recently investigated.However, batch # is required to determine whether this samples are within the same scope as previously investigated.Damaged luer ears: since the samples were damaged during manipulation, the defect could not be confirmed to be attributable to the manufacturing process.Though possibility exists it was related to manufacturing process, it is also possible samples manipulation contributed to the deformation of the ears.Unmanipulated samples with the observed defect with a known batch # are required for investigation of a potential root cause.H3 other text : see h.10.
Event or Problem Description
It was reported that bd threaded lock cannula had a connector defect.This occurred on 2 occasions during use.The following information was provided by the initial reporter: 2 threaded locks turned and never stopped.Also hcp couldn't inject to another threaded lock.

• Brand Name: BD THREADED LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9970062
• Report Number: 2243072-2020-00612
• Device Sequence Number: 2208932
• 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): 05/20/2020

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 Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/20/2020
• 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