MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 19GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305613
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 sharps coll chemo 19gal yellow had a broken lid.The following information was provided by the initial reporter: "it was reported through a phone call that the customer stated they received a case of sharps collectors and 3 out of 5 had broken lids.Per phone call: it was reported through a phone call that the customer stated that they received a case of sharps collectors and 3 out of 5 had broken lids.Please send replacement case and also replacement lids.".
Additional Manufacturer Narrative
H.6.Investigation: a compliant review was performed by the supplier with the sample pictures provided.An investigation was performed to review the in-process inspection of the container.All material is 100% inspected by the production department.Also, a second inspection is performed based on an aql sampling plan by a quality auditor.In addition, a device history review was performed and no issues were found.A complaint history review found no additional complaint for the same part related to this issue.It is possible that the damage occurred in transit during shipping or during the package handling.Based on information provided it wasn¿t possible determine the root cause like a failure mode related to the manufacturing process because there is not enough information like a picture from original packaging to perform an exhaustive investigation.H3 other text : see h.10.
Event or Problem Description
It was reported that sharps coll chemo 19gal yellow had a broken lid.The following information was provided by the initial reporter: "it was reported through a phone call that the customer stated they received a case of sharps collectors and 3 out of 5 had broken lids.Per phone call: it was reported through a phone call that the customer stated that they received a case of sharps collectors and 3 out of 5 had broken lids.Please send replacement case and also replacement lids.".

• Brand Name: SHARPS COLL CHEMO 19GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9869490
• Report Number: 2243072-2020-00471
• Device Sequence Number: 14157608
• Product Code: FMI
• UDI-Device Identifier: 00382903056132
• UDI-Public: 00382903056132
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 04/01/2020

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: 305613
• Device Catalogue Number: 305613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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