MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLL CHEMO 9GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305603
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported bd¿ sharps coll chemo 9gal yellow was missing its lid.The following information was provided by the initial reporter: "it was reported by the consumer the lids were missing.".
Additional Manufacturer Narrative
H.6.Investigation: photos representation was provided for the complaint of missing lids.A dhr review process was made and the result showed there were no issues reported like missing lids during the manufacturing process of the lot number reported under this complaint (b)(4).A review of the ncmr¿s was performed; the result showed there was only one issue reported for the same part number and issue throughout the last twelve months.Investigation: according with the evidence received (picture and information received), it can be seen the following: there are lids missing on the product.We can confirm that the lot number 1134907 was manufactured by flex on 05/14/2021.The product is in its original packaging.With this information it can¿t be determined this failure mode as related to the manufacturing process since the review of the weighing system records for the lot number provided (1134907) was made and no irregularities were detected.There are many variables that can generate this failure mode due to unknown handling and transportation by the distributor when sending the product to the customer, if the material is stored, if there are partial sales or if there were mishandling during the customs review.Additional information on handling and storage within the distributor's facilities is needed to rule out that this problem has been generated by the distributors, since distributors might make partial sales and the controls to handle the remaining material are unknown, therefore, the probability that they send boxes with incorrect quantities could happen.Additionally, as part of the investigation, a review of customer complaint records was conducted according to qc records, two complaints were received during the last twelve months for the same part number and problem.On basis of picture sample being received, an investigation performed and potential root cause will be: non-controlled method to ship partial boxes to end user (re-packaging process).Non-controlled handling (within distributor facilities or during customs revision).
Event or Problem Description
It was reported bd¿ sharps coll chemo 9gal yellow was missing its lid.The following information was provided by the initial reporter: "it was reported by the consumer the lids were missing.".

• Brand Name: BD¿ SHARPS COLL CHEMO 9GAL YELLOW
• 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 ; 8015296192
• MDR Report Key: 14240258
• Report Number: 2243072-2022-00589
• Device Sequence Number: 4887458
• Product Code: FMI
• UDI-Device Identifier: 00382903056033
• UDI-Public: 00382903056033
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 305603
• Device Catalogue Number: 305603
• Device Lot Number: 1134907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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
• Patient Sex: Unknown