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

Model Number	303369
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
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.(b)(4).
Event or Problem Description
It was reported that dirt was found on the bd¿ threaded lock cannula before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about fm (dirt) found on the product before use.".
Event or Problem Description
It was reported that dirt was found on the bd¿ threaded lock cannula before use.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about fm (dirt) found on the product before use.".
Additional Manufacturer Narrative
H6: investigation summary.Five photos and one sealed packaged threaded lock samples, confirmed to be from batch #0049322 (p/n 303369), were received.The sample was visually evaluated.The shield was observed to have numerous foreign matter particles embedded in the cannula¿s shield.The fm was identified as burnt plastic.Some particles were larger than level 3 in size, which is rejectable per product specification.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.Potential root cause for the embedded foreign matter defect is associated with the molding 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.No corrective actions are necessary based on the defective rate identified.Batch 0049322 is considered in compliance with our product specification requirements.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.

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10723511
• Report Number: 1213809-2020-00734
• Device Sequence Number: 1902360
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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 Expiration Date: 01/31/2025
• Device Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: 0049322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 10/29/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown