MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SLIDE CLOSE CHEMO 9GAL; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305604
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that sharps coll slide close chemo 9gal was missing the lid.This was discovered before use.The following information was provided by the initial reporter: material no.: 305604 batch no.: unknown.It was reported a case was received without lids.Per email: we have received a quality complaint on product sold to our customer.Please, respond accordingly with the rma number, if necessary, and the disposition of the customer's concern.Please contact the customer and cc me on any future communication.Injuries or adverse event: no are any samples available for return? yes reported issue: customer receiving 1 cs without lids.
Additional Manufacturer Narrative
H.6.Investigation summary the actual product nor photo representation was provided.A review of the device history record (dhr) was not possible since a lot number could not be provided.Also, a review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months and no manufacturing or material defects were identified that could have caused or contributed to the reported incident, ¿missing lids¿.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.Unfortunately, a weighted label placed on the box by the weighing system is required to identify or confirm this issue.The root cause is unknown.The issue could have occurred during distribution if repackaged by a distributor.Based on these findings, our investigation is inconclusive.Evidence of original packaging is required.Bd will continue to monitor for any trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that sharps coll slide close chemo 9gal was missing the lid.This was discovered before use.The following information was provided by the initial reporter: material no.: 305604 batch no.: unknown it was reported a case was received without lids.Per email: we have received a quality complaint on product sold to our customer.Please, respond accordingly with the rma number, if necessary, and the disposition of the customer's concern.Please contact the customer and cc me on any future communication.Injuries or adverse event: no are any samples available for return? yes reported issue: customer receiving 1 cs without lids.

• Brand Name: SHARPS COLL SLIDE CLOSE CHEMO 9GAL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9495820
• Report Number: 2243072-2019-02859
• Device Sequence Number: 14366047
• Product Code: FMI
• UDI-Device Identifier: 00382903056040
• UDI-Public: 00382903056040
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 01/31/2020

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 Model Number: 305604
• Device Catalogue Number: 305604
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/01/2020
• 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