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

Catalog Number	305272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: 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.Root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 22x1-1/2 rb needle broke.The following information was provided by the initial reporter: it was reported heard a popping noise, and then needle hub snapped and needle broke off in consumers rear end (upper right quadrant).Verbatim: consumer stated her husband was giving her a progesterone injection heard a popping noise, and then needle hub snapped and needle broke off in consumers rear end (upper right quadrant).Consumer reported she went to the emergency room, had x-rays taken, doctor was unable to confirm needle location.Consumer stated doctor dismantled product but could not find needle in syringe; consumer took syringe home, will be sending in for evaluation.Consumer stated she does not want a product replacement; does not feel comfortable using product any longer.Consumer stated she was upset she was forced to jeopardize future pregnancy by undergoing an x-ray.

• 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: 12337775
• Report Number: 1213809-2021-00576
• Device Sequence Number: 3001900
• Product Code: MEG
• UDI-Device Identifier: 00382903052721
• UDI-Public: 00382903052721
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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 Catalogue Number: 305272
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/18/2021
• 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: Required Intervention