MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305781
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: k980987 / k161170.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
It has been reported that the syringe 3ml ll w/ndl eclipse 25x5/8 rb has been found clogged during use.The following has been provided by the initial reporter: it was reported that the needle is clogged.Verbatim: during a several day flu shot clinic we have encountered 5 needles where the needle is clogged and cannot load the syringe with the serum.The syringe is fine its specifically the needle that is clogged.
Event or Problem Description
It has been reported that the syringe 3ml ll w/ndl eclipse 25x5/8 rb has been found clogged during use.The following has been provided by the initial reporter: it was reported that the needle is clogged.Verbatim: during a several day flu shot clinic we have encountered 5 needles where the needle is clogged and cannot load the syringe with the serum.The syringe is fine its specifically the needle that is clogged.
Additional Manufacturer Narrative
Investigation summary: two actual samples were subjected to visual inspection to check for clogged needle where clogged needle was observed for both actual samples.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Vision system challenge: the sample was challenged at the automated vision system at the eclipse needle assembly line.Sample found with clogged needles from the visual inspection was able to be detected and rejected by the vision system.Able to confirm the customer experience as actual sample was observed with clogged needle.Conclusion: probable cause for clogged needle could be parts not rejected by the vision system at the assembly machine due to slanted rack pin.The slanted rack pin would result in the reject cylinder unable to completely reject the identified clogged needles resulting in the escape of the non-conformance part.The following actions had been implemented to address to the clogged needle complaint: conducted a 100% check on the current rack and removed non-conformance racks on apr 2019.Conducted awareness training to the production technicians on this non-conformance and to perform check on the racks before load onto the machine on may 2019.The batch is produced in july 2018 which is before the action implementation.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9355341
• Report Number: 8041187-2019-00925
• Device Sequence Number: 19558749
• Product Code: FMI
• UDI-Device Identifier: 30382903057819
• UDI-Public: 30382903057819
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10
• 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): 12/06/2019

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: 06/30/2023
• Device Catalogue Number: 305781
• Device Lot Number: 8171414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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