MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/INTERLINK VAC; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303401
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Fda device problem code: (b)(4).Fda patient problem code: (b)(4).
Event or Problem Description
It was reported that syringe 3ml ll w/interlink vac was damaged.The following information was provided by the initial reporter: material no.: 303401 batch no.: 0150230 it was reported that the staff is experiencing quality issues with the syringe.Per email: "i've had many staff reporting quality issues, and the staff are not happy with the product overall.The previous item allowed nursing to insert and remove several times (into the same syringe).This product does not allow for this.".
Event or Problem Description
It was reported that syringe 3ml ll w/interlink vac was damaged.The following information was provided by the initial reporter: material no.: 303401 batch no.: 0150230.It was reported that the staff is experiencing quality issues with the syringe.Per email: "i've had many staff reporting quality issues, and the staff are not happy with the product overall.The previous item allowed nursing to insert and remove several times (into the same syringe).This product does not allow for this.".
Additional Manufacturer Narrative
H.6.Investigation: two photos were received and evaluated.One photo displayed a loose 3ml syringe with plastic cannula attached.One photo displayed a blister pack from batch 0150230 (p/n 303401).It was observed the plastic cannula was bent in a 90-degree angle at the hub connection.Based on the verbatim, the defect does not appear to be manufacturing related.Please note, this product is intended for single use to be used on preslitted interlink injection sites after taking medication out of a single dose drug vials and is not compatible with conventional injection sites.Potential root cause for the bent cannula defect may be associated with customer misuse.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.

• Brand Name: SYRINGE 3ML LL W/INTERLINK VAC
• 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: 11131273
• Report Number: 1213809-2021-00004
• Device Sequence Number: 631819
• Product Code: FMI
• UDI-Device Identifier: 30382903034018
• UDI-Public: 30382903034018
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• 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): 01/15/2021

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: 04/30/2025
• Device Model Number: 303401
• Device Catalogue Number: 303401
• Device Lot Number: 0150230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1