MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE WITH BD SAFETYGLIDE SAFETY NEEDLE; PISTON SYRINGE

Model Number	305904
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: hypodermic single lumen needle.Medical device type: fmi.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: (b)(4).Pma / 510(k)#: (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 1" needles were found in the box of bd luer-lok¿ syringes with bd safetyglide¿ safety needles.The following information was provided by the initial reporter: "we have an issue with one of our products (b)(4).We have a case with the lot # 9255272 that is supposed to be a 5/8¿ needle, but the boxes are a mix of 5/8¿ and 1¿ needles.".
Event or Problem Description
It was reported that 1" needles were found in the box of bd luer-lok¿ syringes with bd safetyglide¿ safety needles.The following information was provided by the initial reporter: "we have an issue with one of our products (mfg # 305904).We have a case with the lot # 9255272 that is supposed to be a 5/8¿ needle, but the boxes are a mix of 5/8¿ and 1¿ needles.".
Additional Manufacturer Narrative
H.6.Investigation: four opened resealed shelf cartons were received, confirmed to be from batch #9255272 (305904).The samples inside were confirmed to be from the same batch and all were visually evaluated.One carton had no defective samples, while three cartons had incorrect 1¿ needle length product inside correctly labeled 5/8¿ packages.The number of packages with incorrect 1¿ needles in the three cartons was 10/46, 38/47, and 43/49.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

• Brand Name: BD LUER-LOK SYRINGE WITH BD SAFETYGLIDE SAFETY NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11121044
• Report Number: 1213809-2020-00946
• Device Sequence Number: 3698413
• Product Code: FMF
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• 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): 01/27/2021

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: 08/31/2024
• Device Model Number: 305904
• Device Catalogue Number: 305904
• Device Lot Number: 9255272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1