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

Model Number	305781
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.Date of event: unknown.The date received by manufacturer has been used for this field.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 the syringe 3ml ll w/ndl eclipse 25x5/8 rb was blocked during the meningococcal b vaccine injection.The following information was provided by the initial reporter, translated from (b)(6) to english: "came for 2nd vaccination meningococcal b.During the intramuscular vaccination in the left upper arm, no fluid came out of the needle.A colleague who was also present during the consultation looked on.This colleague also felt resistance when injecting the fluid.It was not possible to inject the vaccine into the right arm.The needle was removed from the arm.This safety needle was removed and kept for a while to check for effusions after the consultation.(this was not the case) the vaccine was injected again in left upper arm.This time no safety needle was used but needle that was provided.Injection now went without any problem.Prior to vaccination meningococcal fluid had been checked for clarity, fluid was not cloudy, vaccine was not overdue.".
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl eclipse 25x5/8 rb was blocked during the meningococcal b vaccine injection.The following information was provided by the initial reporter, translated from dutch to english: "came for 2nd vaccination meningococcal b.During the intramuscular vaccination in the left upper arm, no fluid came out of the needle.A colleague who was also present during the consultation looked on.This colleague also felt resistance when injecting the fluid.It was not possible to inject the vaccine into the right arm.The needle was removed from the arm.This safety needle was removed and kept for a while to check for effusions after the consultation.(this was not the case) the vaccine was injected again in left upper arm.This time no safety needle was used but needle that was provided.Injection now went without any problem.Prior to vaccination meningococcal fluid had been checked for clarity, fluid was not cloudy, vaccine was not overdue.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.See h.10.

• 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: 11585863
• Report Number: 8041187-2021-00220
• Device Sequence Number: 2955328
• Product Code: FMI
• UDI-Device Identifier: 30382903057819
• UDI-Public: 30382903057819
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 09/30/2021
• Device Model Number: 305781
• Device Catalogue Number: 305781
• Device Lot Number: 6265496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR