MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

Catalog Number 309658

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.The medical device expiration date is unknown as the lot number is unknown.(b)(4).(b)(6).The device manufacture date is unknown as the lot number is unknown.Device evaluation: results- a sample is not available for investigation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion- without a sample, an absolute root cause for this incident cannot be determined.If further information is received after this time, a supplemental report will be filed.

Event Description

It was reported that the clinic nurse was giving an injection when the needle (device unknown) dislodged from the suspect device and the patient did not received his entire dose of medication.The physician was notified and prescribed an oral supplementation for the patient to take until his next injection.

• Brand Name: BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6008691
• MDR Text Key: 56765470
• Report Number: 1213809-2016-00030
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 309658
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention