MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB; PISTON SYRINGE

Model Number	305272
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
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 3ml w/ndl 22x1-1/2 rb had a needle retraction failure.The following information was provided by the initial reporter: material no:305272 batch no: 9142823.It was reported that the needle has never retracted after the injection.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 22x1-1/2 rb had a needle retraction failure.The following information was provided by the initial reporter: material no:305272, batch no: 9142823.It was reported that the needle has never retracted after the injection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-12-11.H6: investigation summary two loose 3ml integra syringes and one opened blister pack from batch 9142823 (p/n 305272) were received and evaluated.It could not be determined if either syringe was manipulated.It was observed both syringes had the plunger rod in the bottom out position with the retraction mechanism not activated.The thumb rest was depressed on both syringes and the retraction mechanism functioned as expected with the cannula being concealed inside.No defects were observed.The reported defect was not identified in the samples received.Furthermore, 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 INTEGRA 3ML W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10909576
• Report Number: 1213809-2020-00843
• Device Sequence Number: 19452316
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 05/31/2024
• Device Model Number: 305272
• Device Catalogue Number: 305272
• Device Lot Number: 9142823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1