MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML LL; PISTON SYRINGE

Model Number	305283
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
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.(b)(4).
Event or Problem Description
It was reported that syringe integra 3 ml ll leaked.The following information was provided by the initial reporter: "it was reported the medication leaked out of the barrel as if it was cracked.Per email: i am reaching out to you again, this time about an incident we had on one of our patient care units which involved a bd integra 3 ml syringe ref 305283 that reportedly leaked while giving an im injection of clopixol depot.According to the nurse, "medication seeped from the middle of the barrel of the syringe¿as if cracked." the syringe info is: lot 8092763cav16, exp 2023/03/31.Since this happened a couple weeks ago, i was able to find only 3 samples in case you needed to test them.".
Additional Manufacturer Narrative
H.6.Investigation: three 3ml integra syringes in fully sealed blister packs from batch 8092763 (p/n 305283) were received and evaluated.One of the syringes was observed to have two small indentations near the middle of the barrel.The indentations were not significant enough to puncture the barrel and appeared to be cosmetic in nature with no effect to the form fit or function of the device, which was acceptable per product specification.A potential root cause for the damaged barrel defect is associated with the assembly process.Since the defects observed are within the acceptable limits, no corrective actions are required at this time.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe integra 3ml ll leaked.The following information was provided by the initial reporter: "it was reported the medication leaked out of the barrel as if it was cracked.Per email: i am reaching out to you again, this time about an incident we had on one of our patient care units which involved a bd integra 3 ml syringe ref305283 that reportedly leaked while giving an im injection of clopixol depot.According to the nurse, "medication seeped from the middle of the barrel of the syringe¿as if cracked." the syringe info is: lot 8092763cav16 exp 2023/03/31 since this happened a couple weeks ago, i was able to find only 3 samples in case you needed to test them.".

• Brand Name: SYRINGE INTEGRA 3ML LL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10412998
• Report Number: 1213809-2020-00536
• Device Sequence Number: 14187788
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 03/31/2023
• Device Model Number: 305283
• Device Catalogue Number: 305283
• Device Lot Number: 8092763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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