MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT PEARL; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305444
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Device expiration date: n/a.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.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 the sliding part on a sharps coll side entry 5.4qt pearl was not connected.
Additional Manufacturer Narrative
Investigation summary: dhr/ncmr review: according to the dhr review process; the result showed there were no issues reported like lid broken / damaged (sliding part not connected) 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 lid broken / damaged (sliding part not connected) for the same part number throughout the last twelve months.Investigation: according with pictures provided from customer it can be seen the following: 1.The product reported belong to lot number 8193912 and part number 305444.2.The sliding door is disassembled.During this investigation it was noticed that the product was sold by a distributor as well that they are using them own packaging which it means that the product is being repackaged; therefore additional information from the distributor is needed in order to ensure that this kind of packaging is reliable to keep the integrity of the product during the shipment (transit test).Conclusion: based on this investigation it was not possible determine the root cause like a failure mode related to the manufacturing process since there is enough evidence (according to pictures received it can be seen damages that could be cause by transportation) to confirm that the material was repackaged and shipped in a different packaging.
Event or Problem Description
It was reported that the sliding part on a sharps coll side entry 5.4qt pearl was not connected.

• Brand Name: SHARPS COLL SIDE ENTRY 5.4QT PEARL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8374274
• Report Number: 2243072-2019-00344
• Device Sequence Number: 18937441
• Product Code: FMI
• UDI-Device Identifier: 50382903054447
• UDI-Public: 50382903054447
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 305444
• Device Lot Number: 8193912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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