MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3 ML SYRINGE WITH DETACHABLE 21 G X 1 1/2 IN. NEEDLE; PISTON SYRINGE

Model Number	305274
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd integra¿ 3 ml syringe with detachable 21 g x 1 1/2 in.Needle was damaged.This was discovered during use.The following information was provided by the initial reporter: using bd integra syringe with retracting needle.On completion of administering the medication, a click was heard and assuming the needle had retracted the staff nurse moved the syringe back to dispose of it.The syringe had actually snapped from the end of the barrel, leaving the needle and green collar in the patient.
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received for evaluation.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.A device history review was conducted for lot number 8317519.Batch 8317519 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.H3: see h.10.
Event or Problem Description
It was reported that bd integra¿ 3 ml syringe with detachable 21 g x 1 1/2 in.Needle was damaged.This was discovered during use.The following information was provided by the initial reporter: using bd integra syringe with retracting needle.On completion of administering the medication, a click was heard and assuming the needle had retracted the staff nurse moved the syringe back to dispose of it.The syringe had actually snapped from the end of the barrel, leaving the needle and green collar in the patient.

• Brand Name: BD INTEGRA 3 ML SYRINGE WITH DETACHABLE 21 G X 1 1/2 IN. NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10209601
• Report Number: 1213809-2020-00425
• Device Sequence Number: 16701331
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/13/2020

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: 10/31/2023
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: 8317519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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