MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 3GAL RECYKLEEN PEARL; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305053
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Oem manufacture: 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.
Event or Problem Description
It was reported that an unspecified number of sharps coll 3gal recykleen pearl experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: material no.305053.Batch no.Unknown.Product came without the hazardous label.
Event or Problem Description
It was reported that an unspecified number of sharps coll 3gal recykleen pearl experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: material no.305053 batch no.Unknown.Product came without the hazardous label.
Additional Manufacturer Narrative
H.6.Investigation summary: the actual product nor photo representation was received.A review of the device history record (dhr) was not possible since the lot was unknown.A review of the non-conforming material report (ncmr) showed no issues reported like missing label for the same part number throughout the last twelve months.Also, the last five lots manufactured for the part number were reviewed and no issues were reported related to missing labels.Currently a visual inspection is performed during the manufacturing process and an omission of the label on the container was possible and could be related to a manufacturing error.Based on the information provided, the root cause could be a human error of omission.According to risk assessment a corrective action is not required at this time.Bd will continue to monitor for any trends.H3 other text : see section h.10.

• Brand Name: SHARPS COLL 3GAL RECYKLEEN PEARL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9124457
• Report Number: 2243072-2019-02122
• Device Sequence Number: 2510147
• Product Code: FMI
• UDI-Device Identifier: 50382903050531
• UDI-Public: 50382903050531
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305053
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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