MAUDE Adverse Event Report: BD CARIBE LTD. CAP TIP SYR LL/LS STER LF BLACK 10/TRA; CONTAINER, LIQUID MEDICATION, GRADUATE

Model Number	308341
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer 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 cap tip syr ll/ls ster lf black 10/tray contained foreign matter.The following information was provided by the initial reporter: it was reported fibers coming off of the packaging.
Additional Manufacturer Narrative
H6.After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2618282-2021-00052 was sent in error.Foreign matter not within the fluid pathway may cause a customer inconvenience but will not lead to any degree of harm/serious injury.This complaint is not mdr reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.H3 other text : see h10.
Event or Problem Description
It was reported that cap tip syr ll/ls ster lf black 10/tray contained foreign matter.The following information was provided by the initial reporter: "it was reported fibers coming off of the packaging.".

• Brand Name: CAP TIP SYR LL/LS STER LF BLACK 10/TRA
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 12436065
• Report Number: 2618282-2021-00052
• Device Sequence Number: 14437426
• Product Code: KYW
• UDI-Device Identifier: 30382903083412
• UDI-Public: 30382903083412
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/24/2021

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 Expiration Date: 01/31/2026
• Device Model Number: 308341
• Device Catalogue Number: 308341
• Device Lot Number: 1034236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1