MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYR 3ML LL W/NDL ECLIPSE 21X1-1/2 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305784
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8327538.Medical device expiration date: 2023-11-30.Device manufacture date: 2018-11-23.Medical device lot #: 8302609.Medical device expiration date: 2023-10-31.Device manufacture date: 2018-10-29.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 1 syr 3ml ll w/ndl eclipse 21x1-1/2 rb tw from lot# 8327538, and 1 syringe from lot# 8302609 leaked before use.The following information was provided by the initial reporter: "cmt: leaks".
Event or Problem Description
It was reported that 1 syr 3ml ll w/ndl eclipse 21x1-1/2 rb tw from lot# 8327538, and 1 syringe from lot# 8302609 leaked before use.The following information was provided by the initial reporter: "cmt: leaks".
Additional Manufacturer Narrative
Investigation summary: one hundred representative eclipse samples and eighty four (fifty representative samples were from batch 8327538 and thirty four representative samples were from batch 8302609) representative samples were received by our quality team for evaluation.Leak testing was performed on all samples received and all samples passed the test.No leakage was observed from the eclipse and syringe product; therefore, the failure cannot be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of the leakage cannot be determined.A review of the device history record revealed no irregularities during the manufacture of the reported lot.

• Brand Name: SYR 3ML LL W/NDL ECLIPSE 21X1-1/2 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9151577
• Report Number: 8041187-2019-00784
• Device Sequence Number: 606737
• Product Code: FMI
• UDI-Device Identifier: 30382903057840
• UDI-Public: 30382903057840
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Catalogue Number: 305784
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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