MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305767
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd eclipse¿ needle's packaging was found damaged and opened up during use.The following information was provided by the initial reporter: "the bd eclipse needle 25g x 1 1/2 with lot # 8314982 is having package issues.The packages are opening up so the integrity of the product seems to be compromised.".
Additional Manufacturer Narrative
H.6.Investigation summary : two photos and five actual samples were received by our quality team for evaluation.Upon visual inspection of the samples it was observed that the sealing was open; therefore, the incident could be verified.However, there was indication that the sealing transferred to the bottom web indicating that the sealing process was completed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the review, no abnormality was detected during the production of the affected batch.The sealing process parameters were reviewed and were within specifications.A root cause could not be established.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that the bd eclipse¿ needle's packaging was found damaged and opened up during use.The following information was provided by the initial reporter: "the bd eclipse needle 25g x 1 1/2 with lot # 8314982 is having package issues.The packages are opening up so the integrity of the product seems to be compromised.".

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9929031
• Report Number: 8041187-2020-00196
• Device Sequence Number: 2817455
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: 30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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): 04/24/2020

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 Expiration Date: 10/31/2023
• Device Model Number: 305767
• Device Catalogue Number: 305767
• Device Lot Number: 8314982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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