MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305783
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Material no.305783, batch no.8333678.It was reported that during use of the bd eclipse¿ bd luer-lok¿ syringe with needle the packages was labeled as 3m 22g x 1.5 needle but contained one inch needles in the package.25 syringes were found to be labeled this way.Found 25 syringes on the shelf that are labelled 3m 22g x 1.5 needle that in have 1 i" needles in the package.
Event or Problem Description
Material no.305783, batch no.8333678.It was reported that during use of the bd eclipse¿ bd luer-lok¿ syringe with needle the packages was labeled as 3m 22g x 1.5 needle but contained one inch needles in the package.25 syringes were found to be labeled this way.Found 25 syringes on the shelf that are labelled 3m 22g x 1.5 needle that in have 1 i" needles in the package.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.Since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.The complaint could not be confirmed and the root cause is undetermined.H3 other text: see h.10.

• Brand Name: BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8890873
• Report Number: 8041187-2019-00629
• Device Sequence Number: 285817
• Product Code: FMI
• UDI-Device Identifier: 30382903057833
• UDI-Public: 30382903057833
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/21/2019

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: 11/30/2023
• Device Catalogue Number: 305783
• Device Lot Number: 8333678
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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