MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305789
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2020
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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that 2 syringes 1ml ll w/ndl eclipse 27x1/2 rb were damaged, but still operable.The following information was provided by the initial reporter: "scratch inner or outer barrel.Customer is sensitive to foreign material and abnormality of drug.After containing drug, she worried the scratch inner or outer barrel that give the bad influence on drug effectiveness.".
Event or Problem Description
It was reported that 2 syringes 1ml ll w/ndl eclipse 27x1/2 rb were damaged, but still operable.The following information was provided by the initial reporter: "scratch inner or outer barrel.Customer is sensitive to foreign material and abnormality of drug.After containing drug, she worried the scratch inner or outer barrel that give the bad influence on drug effectiveness".
Additional Manufacturer Narrative
Investigation summary: two samples were received by our quality team for evaluation.These samples were subjected to visual inspection.For the first sample, a faint scratch mark was found on the outer surface of the barrel and the outer surface of the barrel flange.For the second sample, a faint scratch mark on the outer surface of the barrel collar and the top outer surface of barrel flange.Therefore, the team was able to confirm the customer experience.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.The packaging line was reviewed and there are no contact points that could have caused these faint scratches.The samples were then sent to the supplier plant for further investigation.The investigation from the supplier plant found that the potential root cause for the scratched barrel defect is associated with the assembly process and the scratches appear to be cosmetic in nature with no effect to the form fit or function of the device and were within acceptable standards.

• Brand Name: SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10591300
• Report Number: 8041187-2020-00621
• Device Sequence Number: 2803612
• Product Code: FMI
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 02/28/2023
• Device Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: 8052070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/27/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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