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

Model Number	305782
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1147619 medical device expiration date: 05/31/2026 device manufacture date: 05/27/2021 medical device lot #: 1084899.Medical device expiration date: 03/31/2026.Device manufacture date: 03/25/2021.Medical device lot #: 1204165.Medical device expiration date: 07/31/2026.Device manufacture date: 07/23/2021.Medical device lot #: 0300498.Medical device expiration date: 10/31/2025.Device manufacture date: 10/26/2020.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe).Pma / 510(k)#: k161170 (needle).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 there were scale marking issues on the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.This event occurred 56 times.There was no report of patient impact.The following information was provided by the initial reporter: "syringe scale is skewed.".
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1147619 medical device expiration date: 05/31/2026 device manufacture date: 05/27/2021 medical device lot #: 1084899.Medical device expiration date: 03/31/2026.Device manufacture date: 03/25/2021.Medical device lot #: 1204165.Medical device expiration date: 07/31/2026.Device manufacture date: 07/23/2021.Medical device lot #: 0300498.Medical device expiration date: 10/31/2025.Device manufacture date: 10/26/2020.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe).Pma / 510(k)#: k161170 (needle).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 there were scale marking issues on the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.This event occurred 56 times.There was no report of patient impact.The following information was provided by the initial reporter: "syringe scale is skewed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/14/2022.H.6.Investigation: fifty-six (56) samples were received by our quality team for evaluation.One sample in sealed packaging was received for batch 0300498, three samples in sealed packaging for 1084899, two samples in sealed packaging for 1204165, and forty-seven (47) in sealed packaging and three samples with open packaging for batch 1147619.All samples were subjected to visual inspection.Eleven of the returned samples were observed with slight skewed scale marking, one sample from batch 0300498, three samples from batch 1084899, two samples from batch 1204165, and five samples from batch 1147619.All eleven samples identified with skewed scale marking were subjected to volumetric testing and passed.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.Although there is a slight skew in the scale marking, it does not affect the dosage of the solution as the volumetric test is within specification.An investigation was conducted at the syringe apex printing machine to find the cause of the skewed printing.The printing pad set up plays an important role to achieve good printing on the barrel.With a good printing pad set up, consistent printing is achieved as the printing pad is secured on the printing drum.It was understood that any slight skewed printing was deemed acceptable during routine inspection as this defect does not affect the volumetric test.Therefore, the root cause is attributed to the inattentiveness of the slight skewed printing defect by the production technician during printing pad set-up and by both the manufacturing and quality assurance associate during routine inspection.
Event or Problem Description
It was reported that there were scale marking issues on the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.This event occurred 56 times.There was no report of patient impact.The following information was provided by the initial reporter: "syringe scale is skewed.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13290932
• Report Number: 8041187-2022-00015
• Device Sequence Number: 17245483
• Product Code: FMI
• UDI-Device Identifier: 30382903057826
• UDI-Public: 30382903057826
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: Health Professional
• Device Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown