MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 2GAL PEARL; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305422
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: n/a.The manufacturing location for this product is flextoronics, 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.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 that mixed product was found before use with a sharps coll 2gal pearl.The following information was provided by the initial reporter, "it was reported that three cases of 2 gallon sharps containers arrived with different lids.Per email: the 2 gallon sharps containers have arrived with different lids, which do not fit in the wall cabinets.So, they are unable to use these sharps containers.".
Event or Problem Description
It was reported that mixed product was found before use with a sharps coll 2gal pearl.The following information was provided by the initial reporter, "it was reported that three cases of 2 gallon sharps containers arrived with different lids.Per email: the 2 gallon sharps containers have arrived with different lids, which do not fit in the wall cabinets.So, they are unable to use these sharps containers.".
Additional Manufacturer Narrative
Investigation summary: according to the dhr review process; the result showed there were no issues reported like incorrect lids during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like incorrect lids for the same part number throughout the last twelve months.Investigation: in accordance with the photos received, the following observations were made: the lot number 9112926 was confirmed as manufactured by flex.It was confirmed that the lids were incorrect; the lids belong to a different product of product reported under this complaint.According to evidence provided from customer, the issue was generated due to an incorrect subassembly (box of lids) supplied to molding machine, therefore is a manufacturing issue.As part of the complaint following up, a quality alert will be posted within the manufacturing process in order to make aware all the people involved in the manufacturing of this product.Due to the occurrences detected and risk assessment result, a corrective action will be documented in the capa record car-jrz-00000174.

• Brand Name: SHARPS COLL 2GAL PEARL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8983444
• Report Number: 2243072-2019-01969
• Device Sequence Number: 14079132
• Product Code: FMI
• UDI-Device Identifier: 50382903054225
• UDI-Public: 50382903054225
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/23/2019

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: 305422
• Device Lot Number: 9112926
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other