MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PERCISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305185
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Needle Stick/Puncture (2462)
Date of Event	11/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use, a bd percisionglide¿ needle safety device malfunctioned as an employee was re-capping an 18 gauge needle that was connected to an iv bags with potent api compound solution.As the employee was putting the cap on the needle, ¿the needle managed to puncture through the inside of the plastic cap and out of the side of the cap into her left thumb, this was enough to break the skin and cause a small amount of bleeding.The employee¿s co-workers immediately notified eh&s of the employee's injury and was advised to rinse the wound for 15 minutes under water.The employee then came to eh&s for first aid administration which consisted of a bandage and antiseptic wipe.The bleeding stopped after rinsing and the employee's symptoms were checked throughout the day.No additional symptoms were experienced by the employee.The employee was offered to be taken to the medical clinic but she denied the offer since she wasn't experiencing any abnormal effects.
Additional Manufacturer Narrative
Investigation results: eighty-nine samples from a different batch were returned to the columbus plant for evaluation.There were no needles through the shields therefore failure mode is not verified.Most probable root cause is user error as the needle should not be re-shielded after use, and if this is not possible, a one handed passive recapping technique should be used.It is stated in two places on the shelf carton ¿do not reshield used needles¿, and ¿do not force the shield onto the needle, as the needle may penetrate the shield causing injury¿.Assembly batch 6363513 had 18 visual inspections performed on 1,050 parts with zero defects noted.No notifications were written for this batch, nor for the associated assembly batch.Qn review: no notifications were written for this batch, nor for the associated assembly batch.Dhr review: assembly batch 6363513 had 18 visual inspections performed on 1,050 parts with zero defects noted.Investigation results: eighty-nine samples from a different batch were returned.There were no needles through the shields.Possible root cause: user error.Needles should not be re-shielded after use, and if this is not possible, a one handed passive recapping technique should be used.If corrective/preventative action not required, provide rationale: this is a user technique issue.No capa will be issued.

• Brand Name: BD PERCISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7113282
• Report Number: 1911916-2017-00376
• Device Sequence Number: 19128350
• Product Code: FMI
• UDI-Device Identifier: 30382903051855
• UDI-Public: 30382903051855
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 305185
• Device Lot Number: 7023596
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 02/22/2018
• 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