MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TUBERCULIN SYRINGE W/ PRECISIONGLIDE¿ NEEDLE; CONVENTIONAL SYRINGE

Catalog Number	309624
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda notified?: the initial reporter also notified the fda on (b)(6) 2018 via medwatch #5075717.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 the customer received a package of bd tuberculin syringe(s) w/ precision glide¿ needle(s) that were packaged defectively, such that the sterile barrier was compromised.There was no report of injury or medical interventions.
Additional Manufacturer Narrative
H.6.Investigation summary: twenty-nine sealed assembled 21g 1ml tb syringes were received, confirmed to be from batch # 7087642 (p/n 309624).The samples were visually evaluated.Package cavity: 05, 06.One side of the package was not completely cut, the bottom web was not cut thoroughly, and a piece of the bottom web was still connected between 2 syringe packages.Total 14 groups of connected syringes were found, 2 syringes as a group.One package was found without connection to the other package.The syringes were also found to have opened seal at the improper cut bottom web.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.In-process inspections are conducted at different points within our manufacturing process to ensure our products meet product specification along with acceptance quality limit (aql) requirements.20 pieces are visually inspected every hour at the packaging process to confirm product quality.A complaint history check for lot 7087642 was performed, this is the first complaint received for open seal.Investigation conclusion: several potential failure modes at the cutting station were identified during root causes analysis performed with subject matter experts.These include, worn crosscut springs located at the bottom and top could cause incomplete/rough knife cuts in packages, worn cylinder block could cause incomplete/rough knife cuts in packages, worn cut guide could cause incomplete/rough knife cuts in packages, and worn blades could cause incomplete/rough knife cuts.Preventive maintenance activities for the crosscut springs, the cylinder block, and the cut guide were added to the 6 weeks plan of the packaging machines.Also, a study is being performed to understand the performance of the blades used in the cutting station.This study will helps us to define replacement frequency based on lifetime.

• Brand Name: BD TUBERCULIN SYRINGE W/ PRECISIONGLIDE¿ NEEDLE
• Common Device Name: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7430366
• Report Number: 1213809-2018-00212
• Device Sequence Number: 16192113
• Product Code: FMF
• UDI-Device Identifier: 30382903096245
• UDI-Public: 30382903096245
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 309624
• Device Lot Number: 7087642
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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