MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	309606
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
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 of the bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip the syringes have been pulling in air and then the medication squirts out all over the place.Verbatim: rep from (b)(6) reported that at a user facility they report that the last 3 boxes of 309606 have been pulling in air which makes it difficult to draw up medication then the medication squirts out all over the place.Issue has been going on a while.
Additional Manufacturer Narrative
Describe event or problem: it was reported that during use of the bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip there is leakage of medication the medication squirts out all over the place.
Event or Problem Description
It was reported that during use of the bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip there is leakage of medication the medication squirts out all over the place.Verbatim: rep from mckesson reported that at a user facility they report that the last 3 boxes of 309606 have been pulling in air which makes it difficult to draw up medication then the medication squirts out all over the place.Issue has been going on a while.
Additional Manufacturer Narrative
H.6.Investigation: 137 sealed packaged 3ml safety-lok syringes were received, confirmed to be from batch #8340869 (p/n 309606).Each syringe was individually evaluated.No damage or molding defects were observed in any of the 137 returned syringes.Furthermore, 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.Potential root cause for leakage/pulling in air is not associated with manufacturing process but is possibly associated with end user¿s connecting product to the needle/other mating device.The reported defect was not identified in the samples received.
Event or Problem Description
It was reported that during use of the bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip there is leakage of medication the medication squirts out all over the place.

• Brand Name: BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8464992
• Report Number: 1213809-2019-00389
• Device Sequence Number: 1633720
• Product Code: FMI
• UDI-Device Identifier: 30382903096061
• UDI-Public: 30382903096061
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2019

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: 11/30/2023
• Device Catalogue Number: 309606
• Device Lot Number: 8340869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019; 03/07/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/08/2019; 04/30/2019
• 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