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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Potential medical device lot numbers: the lot number involved was either 9323673 or 9340414.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.
Event or Problem Description
It was reported that bd threaded lock cannula was damaged, but still operable.The following information was provided by the initial reporter: "a needle of threaded lock was short and hcp couldn't inject even connected.".
Event or Problem Description
It was reported that bd threaded lock cannula was damaged, but still operable.The following information was provided by the initial reporter: "a needle of threaded lock was short and hcp couldn't inject even connected.".
Additional Manufacturer Narrative
H6.Investigation: multiple photos were received and evaluated.The photos appeared to depict six loose threaded lock pieces, all from cavity 43.All six pieces had short cannula condition, which is rejectable per product specification.The photos also depicted six shelf cartons of the product and a close-up of label with batch #9340414 (p/n 303369) visible.Three shelf cartons confirmed to be from batch #9340414 (p/n 303369) were received, each containing 100 sealed packaged threaded lock units.All samples were visually evaluated.In total 6 defective pieces with short cannula were found out of the 300 inspected.294 pieces had no defects.The 6 defective pieces were: cavity #43 in one carton, cavity #10, 43 in one carton, and cavity #1, 43, 43 in one carton.No sample or photos from batch #9323673 were received.The defect of molding defective was confirmed.On the samples from cavity 1 and 10, there was no defect found.Parts were assembled with an interlink connector in the large threaded end and leak tested with air.There was no evidence of leakage.Defect of part leakage could not be confirmed and there is no physical nonconformity in the part that would cause leakage.This condition 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.All quality checks for that lot were performed per established quality controls and passed (as evident from the dhr review), therefore there is no reason to suspect that cooling of the pin was interrupted for a long time.Retain samples for this lot were no longer available but retain samples from the lot molded in january 2020 were inspected: the defect was not observed.This further suggests that the reported defect was most likely a ¿blip¿, such as a temporary blockage of a cooling flow.A pm (preventative maintenance) is required after running 21 days.Each production run is about 7 days.With infrequent runs, 2 years had elapsed since the last pm when this run was executed.Probable cause is that the amount of time between pms allowed build-up in the cooling channel of the core pin thereby reducing the cooling in the core pin.Furthermore, 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.H3 other text : see h10.

• 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: 10098711
• Report Number: 1213809-2020-00340
• Device Sequence Number: 886126
• 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): 07/06/2020

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: 05/12/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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