MAUDE Adverse Event Report: BECTON DICKINSON BD¿ NESTABLE SHARPS COLLECTOR; SHARPS CONTAINER

Model Number 305487

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that the bd¿ nestable sharps collector was barcode was partially cut off.The following information was provided by the initial reporter, translated from japanese: the barcode was partially cut off.Product information was missing.(lack of product details).

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.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary: no samples or pictures were received as evidence by the customer.As per customer the barcode was partially cut off.Product information was missing was not verified as per no sample received.Dhr review process to verify if there were issues reported as missing label content during the manufacturing process of this product was not able to be performed since no lot number was provided.A review of ncmr¿s was performed; the results exhibit no issues reported for the same part number and issue throughout the last twelve months.Investigation: as part of this investigation, there is not enough evidence like a picture showing the issue from the missing information on the label and there is no lot number provided, however, within customer complaint report, it¿s mentioned that product information was missing (barcode was partially cut off) however, product label contains two barcodes, for this reason, additional information is needed to determine the root cause of this issue since the secondary barcode is the one that is being printed within our process.If this was the case, this issue can be considered as a failure mode related to the manufacturing process due to omission error within the visual inspection.For this reason, quality alert was implemented to make awareness to the personnel involved and help on prevention of escapes of label with missing content during the manufacturing process.Also, as part of the investigation, a review of customer complaint records was performed and according with the cc¿s records, no complaints were received through the last twelve months for the same part number and matter, for this reason, this is an isolated issue.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: omission error within the visual inspection.Containment action: quality alert was posted to aware all the personnel involved.Corrective action: retraining of the personnel regarding visual inspection of the label.Conclusion: based on the information provided, it was possible to confirm this problem related to the manufacturing process due to an omission error within the visual inspection, for which a quality alert was issued, and staff retraining was carried out.However, the secondary barcode is being printed within our process and this complaint does not specify which barcode the content is missing from.Additional information like sample or picture of the product label is needed to determine if the root cause is from our process or from the vendor.No additional complaints have been received for the same part number and issue, being this considered an isolated issue.

Event Description

It was reported that the bd¿ nestable sharps collector was barcode was partially cut off.The following information was provided by the initial reporter, translated from japanese: the barcode was partially cut off.Product information was missing.(lack of product details).

• Brand Name: BD¿ NESTABLE SHARPS COLLECTOR
• Type of Device: SHARPS CONTAINER
• 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: 16892348
• MDR Text Key: 314815200
• Report Number: 2243072-2023-00767
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903054879
• UDI-Public: (01)00382903054879
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305487
• Device Catalogue Number: 305487
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1