MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305900
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 1 out of 20 total needles sftygld 22x1-1/2 rb was found with foreign matter in it before use, during a visual evaluation inspection.This complaint was created to capture the 9th of 9 related incidents.The following information was provided by the initial reporter: "305900 -ndl, 22g x 1.5 safety glide- 1 out of 20 found to have loose particulate." as part of our continuous improvement activities, the medical facility has undertaken an extensive visual evaluation of incoming components to characterize possible source of foreign material.The table below highlights the results of that inspection.Overall, 6.4 % had some type of loose particulate.(b)(6).
Additional Manufacturer Narrative
H.6.Investigation: 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.H3 other text : see h.10.
Event or Problem Description
It was reported that (b)(4) out of (b)(4) total needles sftygld 22x1-1/2 rb was found with foreign matter in it before use, during a visual evaluation inspection.This complaint was created to capture the 9th of 9 related incidents.The following information was provided by the initial reporter: "305900 -ndl, 22g x 1.5 safety glide- (b)(4) out of (b)(4) found to have loose particulate." as part of our continuous improvement activities, the medical facility has undertaken an extensive visual evaluation of incoming components to characterize possible source of foreign material.The table below highlights the results of that inspection.Overall, 6.4 % had some type of loose particulate.Total loose: # inspected percentage: bd part # internal avid# description 682 10589 6.4% 304134 500604 syr, 10cc control l/l 6 52 11.5% 301073 500605 syr, 3cc l/l 43 1581 2.7% 301031 500608 syr, 20cc l/l 68 913 7.4% 301033 500609 syr, 30cc l/l 95 788 12.1% 301035 500611 syr, 60cc l/l 33 132 25.0% 301029 500620 syr, 10cc l/l 433 7016 6.2% 303005 500640 ndl, 18g x 1.5" rg bev 1 21 4.8% 381147 508408 angiocath 18g x 1.88" iv cath 2 66 3.0% 305900 509337 ndl, 22g x 1.5 safety glide 1 20 5.0%.

• Brand Name: NEEDLE SFTYGLD 22X1-1/2 RB
• 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: 8964673
• Report Number: 1213809-2019-00890
• Device Sequence Number: 19496684
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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 Catalogue Number: 305900
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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