MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE¿ 5ML LL W/NEEDLE 22X1-1/2IN RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305785
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Pma / 510(k)#: k980987 (syringe); k161170 (needle).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe¿ 5ml ll w/needle 22x1-1/2in rb safety shield did not completely cover needle which resulted in the nurse being stuck by the needle.
Additional Manufacturer Narrative
Investigation: dhr for lot number 8029598 was reviewed and no qns or other events were related to the complaint stated by the customer.The sample received was visually inspected and it shows the needle not completely covered by the safety cover causing to have the tip of the needle exposed and causing that the nurse get stunk, the cause of the tip exposure was due that the safety cover was not molded correctly, on this order it get inspected and packed 100,860 syringes with needles and during the inspection no needle exposure were found on the material.With this condition we can confirm the issue stated by the customer with the sample received from customer, after that we inspect the retain samples, on this case we did not find any failure as the one showed on the sample received from the customer, we can assign this issue as raw material issue from supplier, this defect could not be observed during the inspection process due that the needle has a second cover and there is no way to check if the main cover it is placed correctly.
Event or Problem Description
It was reported that bd syringe¿ 5ml ll w/needle 22x1-1/2in rb safety shield did not completely cover needle which resulted in the nurse being stuck by the needle.

• Brand Name: BD SYRINGE¿ 5ML LL W/NEEDLE 22X1-1/2IN 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
• MDR Report Key: 8373932
• Report Number: 9610847-2019-00188
• Device Sequence Number: 2120371
• Product Code: FMI
• UDI-Device Identifier: 00382903057856
• UDI-Public: 00382903057856
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• 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): 05/03/2019

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 305785
• Device Lot Number: 8029598
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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