MAUDE Adverse Event Report: BECTON DICKINSON BD HOME SHARPS CONTAINER; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	9601
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
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: n/a.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd home sharps container needle will not fit into the container.This was discovered during use.The following information was provided by the initial reporter: material no.323487 batch no.9213001.It was reported that she can not dispose the needle from her insulin pump in container.Has to use screwdriver to push inside.Issue: consumer reported she cannot dispose the needle from her insulin pump in this container, she had to use screwdriver to push.Her husband orders her containers, she is not sure which size he had ordered in the past.Explained this container may not be compatible for needles to dispose.Explained to check with the suppliers to send the right size she was getting in the past.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.As per dhr completed by manufacturing, ¿no ncr¿s were raised during the production of this lot.All testing was within specification.¿ h3 other text : see h.10.
Event or Problem Description
It was reported that bd home sharps container needle will not fit into the container.This was discovered during use.The following information was provided by the initial reporter: material no.323487 batch no.9213001 it was reported that she can not dispose the needle from her insulin pump in container.Has to use screwdriver to push inside.Issue: consumer reported she cannot dispose the needle from her insulin pump in this container, she had to use screwdriver to push.Her husband orders her containers, she is not sure which size he had ordered in the past.Explained this container may not be compatible for needles to dispose.Explained to check with the suppliers to send the the right size she was getting in the past.

• Brand Name: BD HOME SHARPS CONTAINER
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9538981
• Report Number: 2243072-2019-02933
• Device Sequence Number: 19466769
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: Lay User/Patient
• Device Model Number: 9601
• Device Catalogue Number: 323487
• Device Lot Number: 9213001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/08/2020
• 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