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

Catalog Number	305283
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
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 syringe integra 3ml ll needle broke during use.The following information was provided by the initial reporter: faulty integra needle syringe system.The rn was giving a thick oily based antipsychotic medication, partway giving the medication, needle was in the patient skin, the needle head detached from the syringe, attached only by the spring and the needle left dangling.Stated they had previously has a syringe leak fluid at this spot but didn't report it or document anywhere.
Event or Problem Description
It was reported that syringe integra 3ml ll needle broke during use.The following information was provided by the initial reporter: faulty integra needle syringe system.The rn was giving a thick oily based antipsychotic medication, partway giving the medication, needle was in the patient skin, the needle head detached from the syringe, attached only by the spring and the needle left dangling.Stated they had previously has a syringe leak fluid at this spot but didn't report it or document anywhere.
Additional Manufacturer Narrative
H.6.Investigation summary: one loose integra syringe covered in yellowish fluid inside a biohazard bag was received and evaluated.It was observed the hub was disconnected and the spring was loose in the bag.The stopper was at the 0.1ml marking, which is the expected location after normal retraction.No defect was observed on the manipulated sample.It is possible the hub was not fully tightened onto the syringe.The reported defect could not identified in the sample received.The sample was manipulated and covered in unknown medication and only a limited evaluation could be performed.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 9695375
• Report Number: 1213809-2020-00082
• Device Sequence Number: 14204041
• Product Code: MEG
• UDI-Device Identifier: 00382903052837
• UDI-Public: 00382903052837
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 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: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 305283
• Device Lot Number: 7235634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/11/2020
• 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