MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO NDL BLUNT FILL 18X1-1/2 NRFIT SSU; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	400067
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.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 was reported that ndl blunt fill 18x1-1/2 nrfit ssu separated from the syringe.The following information was provided by the initial reporter: bd blunt needle without the nrfit connector.It has become disconnected from the needle when is disconnecting from an nrfit syringe.
Additional Manufacturer Narrative
H.6.Investigation: one photo received for investigation, upon observation cavity of the nrfit adapter is seen separated from the connector.Possible root cause is lack of glue placement on the product.Corrective action include the possible installation of a white light lamp to visually check the placement of the glue on the base for the needle.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that ndl blunt fill 18x1-1/2 nrfit ssu separated from the syringe.The following information was provided by the initial reporter: bd blunt needle without the nrfit connector.It has become disconnected from the needle when is disconnecting from an nrfit syringe.

• Brand Name: NDL BLUNT FILL 18X1-1/2 NRFIT SSU
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 12185967
• Report Number: 9614033-2021-00081
• Device Sequence Number: 14638282
• Product Code: GAA
• UDI-Device Identifier: 00382904000677
• UDI-Public: 00382904000677
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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): 09/29/2021

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 Catalogue Number: 400067
• Device Lot Number: 0315426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1