MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE

Catalog Number	305764
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
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 before use of the bd eclipse¿ needle during the incoming inspection of bd eclipse needle (supplier lot number 7176189) the pfizer rochester site found an unsealed needle packet.Per the rochester incoming inspection this is considered a critical defect and the inspection lot is rejected.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Results: bd received one actual sample and four representative samples from the customer in support of this complaint.Open seal was observed on the actual sample and the packaging of 4 representative samples were found to be intact.The actual sample was subjected to further evaluation.A tiny hole was observed on the bottom web film.Dhr ¿ no abnormality and qn was reported during production.Conclusion: the tiny holes on the bottom web film caused shallow pocket during the forming process.The hole caused the vacuum loss and the pocket failed to form properly.Manufacturing record has been reviewed, there is no damage on the forming surface which could cause the nonconforming on the bottom web.No qn was raised for open seal.The nonconformance found on the bottom web could be probably originated from the raw material.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7160927
• Report Number: 8041187-2017-00296
• Device Sequence Number: 1863407
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: 07/31/2022
• Device Catalogue Number: 305764
• Device Lot Number: 7176189
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/26/2018
• 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