MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML TUBERCULIN SYRINGE SLIP TIP W/DETACHABLE NEEDLE; PISTON SYRINGE

Model Number	309625
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd 1ml tuberculin syringe slip tips w/detachable needles experienced the needle and syringe separating/spinning out during use.The following information was provided by the initial reporter: material no: 309625 batch no: 9353360.It was reported that when rn is administering an immunotherapy injection, the needle remains in the patient and the patient does not receive the appropriate dose ordered.After discussing this with management, we felt that it wasn't necessary to send samples in for investigation.As previously mentioned, the more we looked into this issue, we realized we could have been using the needles with a more compatible luer lock style syringe.Moving forward we would like to implement this, and expect that using the luer lock syringe would prevent any further malfunctions.I believe it has occurred approximately 4 times.Twice this month on (b)(6) 2020 and (b)(6) 2020 for two different rn's.Lot # 9361589, ref# (b)(4) for needle.Lot # 9353360, ref# (b)(4) for syringe.As i mentioned in the previous email, upon further investigation, we believe this occurred because we of the type of syringe we were using.If you would still like a sample to investigate the product, please let me know how to go about sending that.Our medical assistant just recently placed an order for the 1ml tb syringe with luer lock, so hopefully this problem will resolve itself.We are hopeful that changing the syringe will prevent this issue from happening in the future.
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received for evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are required at this time.A device history review was conducted for lot number: 9353360.
Event or Problem Description
It was reported that an unspecified number of bd 1ml tuberculin syringe slip tips w / detachable needles experienced the needle and syringe separating / spinning out during use.The following information was provided by the initial reporter: material no: 309625, batch no: 9353360.It was reported that when rn is administering an immunotherapy injection, the needle remains in the patient and the patient does not receive the appropriate dose ordered.After discussing this with management, we felt that it wasn't necessary to send samples in for investigation.As previously mentioned, the more we looked into this issue, we realized we could have been using the needles with a more compatible luer lock style syringe.Moving forward we would like to implement this, and expect that using the luer lock syringe would prevent any further malfunctions.I believe it has occurred approximately 4 times.Twice this month on (b)(6) 2020 for two different rn's.Lot#: 9361589, ref#: 305758 for needle.Lot#: 9353360, ref#: 309625 for syringe.As i mentioned in the previous email, upon further investigation, we believe this occurred because we of the type of syringe we were using.If you would still like a sample to investigate the product, please let me know how to go about sending that.Our medical assistant just recently placed an order for the 1ml tb syringe with luer lock, so hopefully this problem will resolve itself.We are hopeful that changing the syringe will prevent this issue from happening in the future.

• Brand Name: BD 1ML TUBERCULIN SYRINGE SLIP TIP W/DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10418381
• Report Number: 1213809-2020-00541
• Device Sequence Number: 2618154
• Product Code: FMF
• UDI-Device Identifier: 30382903096252
• UDI-Public: 30382903096252
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• 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): 08/25/2020

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: 11/30/2024
• Device Model Number: 309625
• Device Catalogue Number: 309625
• Device Lot Number: 9353360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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