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

Catalog Number	305765
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 illegible label print was observed on the bd eclipse¿ needle before use.The following information was provided by the initial reporter: "during incoming inspection of lot 9028581 we observed primary packs where the variable lot data is not printed totally readable: inspected number n=80.Within the inspected random samples (n=80) we found five affected blocks of blister strips.At two of five blisters the lot number (9028581: second 8 becomes 3) is not readable/unclear (altogether 16 within n=80).".
Additional Manufacturer Narrative
Investigation: our quality engineer inspected the returned product and confirmed the reported observation of illegible print on the top web of the packaging.The manufacturing process was reviewed.The variable print information was printed onto the top web by the printer at the primary packaging machine.Machine stoppages may have caused the printer head to be partially choked thus, creating illegible print.Whenever the printer head becomes choked, production technicians are required to clean the printer head.Currently, there is an hourly in-process inspection to check for illegible/missing print and weekly preventive maintenance to clean the printer head.In this case, the production technician may have cleaned the printer head but overlooked removing the impacted product at the slitting station allowing defective packaging to continue down the good product stream.Photo evaluation 1 photo was received for investigation and observed illegible print on the topweb.Sample evaluation 25 actual unused samples were received for investigation.The 25 samples were subjected to visual inspection to check for illegible print.Illegible print on topweb was observed on all the returned samples dhr was performed and there were nmo illegible print rejects at the outgoing inspection.
Event or Problem Description
It was reported that illegible label print was observed on the bd eclipse¿ needle before use.The following information was provided by the initial reporter: "during incoming inspection of lot 9028581 we observed primary packs where the variable lot data is not printed totally readable: inspected number n=80.Within the inspected random samples (n=80) we found five affected blocks of blister strips.At two of five blisters the lot number (9028581: second 8 becomes 3) is not readable/unclear (altogether 16 within n=80).".

• 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: 8687660
• Report Number: 8041187-2019-00439
• Device Sequence Number: 1941936
• Product Code: FMI
• UDI-Device Identifier: 30382903057659
• UDI-Public: 30382903057659
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 01/31/2024
• Device Catalogue Number: 305765
• Device Lot Number: 9028581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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