MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305487
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.H.3.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 while using bd¿ phlebotomy sharps collector, 1.5 qt needle port the lid was difficult to close.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: customer reported that the lid didn't shut when assembled.
Event or Problem Description
It was reported while using bd¿ phlebotomy sharps collector, 1.5 qt needle port the lid was difficult to close.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: customer reported that the lid didn't shut when assembled.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-may-2023.H6: investigation summary: 2 sample(s) received by customer and investigation performed and verified the issue.A dhr review was performed, the result showed there were no issues reported like assembly difficult for the lot number reported (2283936) under this complaint.Also, a review of the ncmr¿s was performed; the result showed nothing reported for the same part number and issue throughout the previous twelve months.Investigation: according with the pictures provided from customer it can be seen the following: 1.It can be noticed that the skirt of the product is warped/deformed.2.The lot number 2283936 reported under this complaint was manufactured by flex on october 10, 2022.Based on this investigation and information provided (pictures and lot number), within the report, customer describes that lid does not shut when assembled.With the collected information, it can be concluded that this issue could be related to the manufacturing process since the defect in the skirt area could be caused due to rough surface in the core of one of the cavities, causing the plastic part not released in a correct form producing negative force in the plastic part avoiding the correct ejection and suffering a warpage in the top of the base, however, sample is needed in order to determine the root cause of this issue.Additionally, line clearance could have not performed properly at the time to withdraw defective pieces.Current molding process was visited by involved personnel, molded parts were reviewed; the manufacturing instructions for molding - assembly process was reviewed and compared with the current practices made by the operator and was found that process is followed as is described in the manufacturing instructions.As part of the investigation, a review of the customer complaint records was performed and the result showed two additional complaints reported for the same issue and part number throughout the last twelve months, being this considered an isolated issue.These previous complaints were closed as incomplete since no sample was provided.As per the defective sample investigation the root cause will be: 1.End user misuse (the end user didn¿t follow the steps stated in the bd sharps collector ifu).2.Manufacturing process line clearance was not performed properly at the time to withdraw defective pieces.3.Manufacturing process incorrect handling, use, storage, transportation issues or inappropriate environment could have caused deformation.Corrective action: personnel was retrained regarding workstation clearance to prevent escapes of defective pieces.Containment action: quality alert was posted from previous complaint to aware all the personnel involved in the manufacturing process of this product.Conclusion: based on the evidence provided from customer, this issue could potentially be related to the manufacturing process due to line clearance omission at the time to withdraw defective pieces, however, sample is needed in order to determine the root cause of this issue since this could also be related to user misuse, incorrect handling, use, storage, transportation issues or inappropriate environment that could cause deformation.Nevertheless, a quality alert was posted to aware all the personnel involved in the manufacturing process of this product and personnel was retrained regarding workstation clearance.The current manufacturing process has been evaluated and confirmed that there are controls to detect this kind of defects.If additional information can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.This incident has been added to our database of reported incidents.

• Brand Name: BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17131809
• Report Number: 2243072-2023-01023
• Device Sequence Number: 6458041
• Product Code: FMI
• UDI-Device Identifier: 00382903054879
• UDI-Public: (01)00382903054879
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/30/2023

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: 305487
• Device Catalogue Number: 305487
• Device Lot Number: 2283936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown