MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305786
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter zip: p.O (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syr 10ml ll w/ndl eclipse 22x1-1/2 rb plunger was difficult to move.The following information was provided by the initial reporter: last september we received huge quantity of the above mentioned items.However i have received poor quality reviews from my staffs who are utilizing these items in our blood extractions areas.These are their common comments about the product: no back-flow can be seen in the hub area of the syringe in all extractions done.The maximum amount of blood cannot be extracted from patients at the expected full capacity of the syringe.The items (mostly 5 cc and 10 cc) require an extra effort in pulling the plunger during blood extraction unlike other similar products that we have tried before which can be easily pulled.
Event or Problem Description
It was reported that syr 10ml ll w/ndl eclipse 22x1-1/2 rb plunger was difficult to move.The following information was provided by the initial reporter: last september we received huge quantity of the above mentioned items.However i have received poor quality reviews from my staffs who are utilizing these items in our blood extractions areas.These are their common comments about the product: ¿ no back-flow can be seen in the hub area of the syringe in all extractions done.¿ the maximum amount of blood cannot be extracted from patients at the expected full capacity of the syringe.¿ the items (mostly 5 cc and 10 cc) require an extra effort in pulling the plunger during blood extraction unlike other similar products that we have tried before which can be easily pulled.
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed by our quality engineer team for provided final lot number 9246157 and all applicable sub-assembly lot numbers.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one sample was received for evaluation by our quality engineer team.The product was functionally tested by aspirating the device and the syringe without the needle and minimal difficulty was noticed.The needle was then observed for potential signs of clogging; however, no clogging defects were identified.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this reported incident.See h.10.

• Brand Name: SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10864611
• Report Number: 9610847-2020-00363
• Device Sequence Number: 16812129
• Product Code: FMI
• UDI-Device Identifier: 30382903057864
• UDI-Public: 30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 305786
• Device Catalogue Number: 305786
• Device Lot Number: 9246157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/25/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1