MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE; FLUSH

Catalog Number	306507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Ha device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found on the tip of a 3 ml bd¿ pre-filled normal saline syringe.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: one sample was received for evaluation by our quality engineer team.Upon examination of the product, dark material was seen on the inner surface of the barrel tip.The material was microscopically examined and it was observed to be a brittle, solid material that easily flaked.A small portion of the material was removed and prepared for fourier-transform infrared (ftir) spectral analysis for identification purposes.No spectral results were available through the ftir analysis, which indicates that the material is metallic in nature.Based on the results, the dark material may be rust, resulting from a piece of metal that may have been exposed to the saline within the syringe barrel.One-hundred and twenty retained samples of the same lot number were obtained for evaluation.The retained samples were all visually inspected and no foreign matter was observed.A device history record review did not reveal any issues during the production of lot number 802011c that could have contributed to the reported/observed defect.Lot number 802011c was manufactured within a designated cleanroom which is absent of any metal automated equipment for filling purposes.All possible metal equipment within the cleanroom was observed for signs of metal flaking; no signs were found.The observed foreign matter does not appear to have originated from the bd manufacturing facility.As the raw material for this syringe is manufactured at a supplier location, a supplier corrective action request has been submitted for this issue.As the occurrence for this issue is low and there is currently no trend for foreign matter on product code 306507, further action within the bd facility has been determined unnecessary at this time.
Event or Problem Description
It was reported that foreign matter was found on the tip of a 3 ml bd¿ pre-filled normal saline syringe.There was no report of exposure, injury or medical intervention.

• Brand Name: 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE
• Common Device Name: FLUSH
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7666844
• Report Number: 2134319-2018-00079
• Device Sequence Number: 1409820
• Product Code: NGT
• UDI-Device Identifier: 30382903065074
• UDI-Public: 30382903065074
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: No Information
• Device Expiration Date: 01/19/2021
• Device Catalogue Number: 306507
• Device Lot Number: 802011C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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