MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 14QT RED 1103 NON-VENT CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305456
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: (b)(4).Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the sharps coll 14qt red 1103 non-vent cap was broken before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about a lid issue of sharps container (13.2l).According to the customer's report, the round part of the lid was separated from the container.".
Additional Manufacturer Narrative
H6: investigation summary bd japan recieved a sample, but only a photo of the sample was sent to the manufactur for investigation.Based on the sample photo provided, the following observation were made: 1.Cap of the lid was detached from the hinge.2.There are stress marks in both sides of the hinge.3.The lot number 0052928 was confirmed manufactured by flex.4.The part number 305456 was confirmed like affected lot.5.The rupture of the hinge was uniform.According with this investigation this failure mode had been already identified as part of previous customer complaint (b)(4) which belongs to a different product but uses the same mold for the cap, therefore, as per the previous investigation result it was noticed that the hinge area was found to its minimum thickness specification, that¿s why as part of the improvement action the mold steel was adjusted to give more thickness on the hinge area in order to avoid broken/cracks on the hinge.Due to the lot number (0052928) reported under this complaint was confirmed as manufactured before the improvement action no further actions will be required.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken ¿ damaged issue for the same part number throughout the last twelve months.According to the dhr review process; the result showed there were no issues reported like lid broken ¿ damaged issue during the manufacturing process of the lot number reported under this customer complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that the sharps coll 14qt red 1103 non-vent cap was broken before use.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about a lid issue of sharps container (13.2l).According to the customer's report, the round part of the lid was separated from the container.".

• Brand Name: SHARPS COLL 14QT RED 1103 NON-VENT CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10610832
• Report Number: 2243072-2020-01537
• Device Sequence Number: 1192864
• Product Code: FMI
• UDI-Device Identifier: 00382903054565
• UDI-Public: 00382903054565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305456
• Device Catalogue Number: 305456
• Device Lot Number: 0052928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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