MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305764
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a needle eclipse 21x1 rb tw caused an allergic reaction during use.The following was reported by the initial reporter: "it was reported after injection the pt developed redness, pain and swelling of the left thigh.He had left thigh abscess incision and drainage by the next day.It had gotten worse, so he was admitted for iv antibiotics and packing of the wound verbatim: per customer response, on the e-mail: 11/19/2020.The needle is one that came in a box of bicillin.We¿d never seen a reaction like this after giving this medication so we felt it was worth reporting.I¿m not sure what caused this child¿s abscess, if it was the needle, the medication, the fact that he vomited on the site after the injection was given or what was the cause.The needle was a bd eclipse 21 g 1 in, lot # 7176188, exp.06/30/2022.On (b)(6) 2020, pt received a bicillin injection in his left thigh for tx of strep pharyngitis.Immediately after receiving the injection, he vomited in his lap and on his legs in the area where he had received the injection.Within a day or two of the injection he developed redness, pain and swelling of the left thigh, at/near the injection site by (b)(6) 2020 it had gotten worse and he went to the local children's hospital where he had left thigh abscess incision and drainage by the next day.It had gotten worse, so he was admitted for iv antibiotics and packing of the wound.Fda safety report id # (b)(4)".
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The sterilization records were reviewed, and no abnormalities were observed.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that a needle eclipse 21x1 rb tw caused an allergic reaction during use.The following was reported by the initial reporter: "it was reported after injection the pt developed redness, pain and swelling of the left thigh.He had left thigh abscess incision and drainage by the next day.It had gotten worse, so he was admitted for iv antibiotics and packing of the wound.Verbatim: per customer response, on the attached e-mail: 11/19/2020.The needle is one that came in a box of bicillin.We¿d never seen a reaction like this after giving this medication so we felt it was worth reporting.I¿m not sure what caused this child¿s abscess, if it was the needle, the medication, the fact that he vomited on the site after the injection was given or what was the cause.The needle was a bd eclipse 21 g 1 in, lot # 7176188, exp.06/30/2022.On (b)(6) 2020, pt received a bicillin injection in his left thigh for tx of strep pharyngitis.Immediately after receiving the injection, he vomited in his lap and on his legs in the area where he had received the injection.Within a day or two of the injection he developed redness, pain and swelling of the left thigh, at/near the injection site by (b)(6) 2020 it had gotten worse and he went to the local children's hospital where he had left thigh abscess incision and drainage by the next day.It had gotten worse, so he was admitted for iv antibiotics and packing of the wound.Fda safety report id # (b)(4).".

• Brand Name: NEEDLE ECLIPSE 21X1 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11023784
• Report Number: 8041187-2020-00838
• Device Sequence Number: 3617602
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 06/30/2022
• Device Model Number: 305764
• Device Catalogue Number: 305764
• Device Lot Number: 7176188
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 12/31/2020
• 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: Required Intervention