MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL W/NDL 21X1 RB; PISTON SYRINGE

Model Number	309632
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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: since no samples displaying the reported condition were received a potential root cause could not be defined.
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl 21x1 rb experienced a bron needle and a needle that was loose/pulled out of hub.Product defects were noted during use.The following information was provided by the initial reporter: material no: 309632, batch no: unknown.2020-08-06: received voicemail from consumer with syringe complaint.Consumer stated he had a.5 ml syringe that came apart and he lost an entire vial of medicine due to this.Lg from phone call: consumer returned phone call from voicemail he received from rep.Stated the needle broke off of one of his syringes when drawing up his medication and it went into the medication vial.Stated he lost a whole vial of medication due to this.Stated he has also experienced needle separation towards the end of his injections.Stated this doesn't happen a lot but has happened about 2-3 times.Lg product complaints received a call from a consumer.He mentioned that his luer-lok¿ tip syringe (309632) fell apart as he was about to inject himself with medicine and his medicine spilled on (b)(6) 2020.He was not harmed in any sort of way since this occurred right before injection.He spoke to a bd rep and they said they would replace his medicine and syringes which he just received from his local pharmacy, but never received instruction on what to do with the defective product.Also mentioned he never received a box or envelope to send the faulty syringe back.Also he states, that the needle and plunger are sometimes separated when he receives his packages.Furthermore, he states that this is the 5th time this year that this device has fallen apart.

• Brand Name: SYRINGE 5ML LL W/NDL 21X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10476987
• Report Number: 1213809-2020-00588
• Device Sequence Number: 3546108
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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
• Report Date (Section B): 08/11/2020

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 Model Number: 309632
• Device Catalogue Number: 309632
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/01/2020
• 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