MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305900
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the needle sftygld 22x1-1/2 rb was missing the needle cap and sterility was compromised prior to use.The following information was provided by the initial reporter: verbatim: it was reported that the nurse went to use this needle when she noticed part of the needle was sticking out of the packaging.It appears during the assemble process a cap was not put on the needle.No one was stuck or injured by the needle.The attached pictures of an needle we received.I was told the nurse went to use this needle when she noticed part of the needle was sticking out of the packaging.It appears during the assemble process a cap was not put on the needle.No one was stuck or injured by the needle.I just want to make sure the team is aware in case other departments have found a similar problem and are aware of this incident.I will save the needle is a safe and secure place.Please let me know if any other documentation or reporting needs to be done by our unit regarding this matter.
Additional Manufacturer Narrative
H.6.Investigation: two photos and eleven strips of 5 safetyglide needles were received, split amongst a plastic bag and an opened shelf carton.They were confirmed to be from batch #9316337 (p/n 305900).The samples were visually evaluated.The reported defect was not observed in the returned samples.The photos, however, depicted a single sealed package from the same batch.The needle inside the package had no shield with the cannula having punctured and sticking out of the bottom web.Potential root cause for the missing shield defect is associated with defective product from supplier and the failure to reject potentially defective pieces during the packaging process.Recent work had been done with the vendor to improve incoming product quality.In addition, on the line in-process improvements have been implemented to detect and reject defective product to reduce the chance of needles with missing shield being packaged.Completed: jan 2020.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 the needle sftygld 22x1-1/2 rb was missing the needle cap and sterility was compromised prior to use.The following information was provided by the initial reporter: verbatim: it was reported that the nurse went to use this needle when she noticed part of the needle was sticking out of the packaging.It appears during the assemble process a cap was not put on the needle.No one was stuck or injured by the needle.The attached pictures of an needle we received.I was told the nurse went to use this needle when she noticed part of the needle was sticking out of the packaging.It appears during the assemble process a cap was not put on the needle.No one was stuck or injured by the needle.I just want to make sure the team is aware in case other departments have found a similar problem and are aware of this incident.I will save the needle is a safe and secure place.Please let me know if any other documentation or reporting needs to be done by our unit regarding this matter.

• Brand Name: BD NEEDLE SFTYGLD 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9727980
• Report Number: 1213809-2020-00116
• Device Sequence Number: 3069096
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 9316337
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/16/2020
• 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