MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE INTEGRA 25X1 RB TW; SYRINGE, ANTISTICK

Catalog Number	305311
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material# 305311 batch# 1172469 it was reported that the bd needle integra 25x1 rb tw had a needle retraction failure.The following information was provided by the initial reporter: hi, we have had an issue with a 1" retractable needles.The first is that the needle was not capped while the packaging was still sealed second is that the needle did not retract after a vaccine was administered and the ma tried to engage the safety date occurred: thursday on (b)(6)2024 no injury.Both needle issues were from the same lot number both are lot # 1172469 exp: 12-31-26 customer would like credit for 1 box.
Event or Problem Description
Material# 305311.Batch# 1172469.It was reported by customer that the first is that the needle was not capped while the packaging was still sealed second is that the needle did not retract after a vaccine was administered and the ma tried to engage the safety.Verbatim: rcc received a complaint via phone.Pir attached.Hi, we have had an issue with a 1" retractable needles.The first is that the needle was not capped while the packaging was still sealed second is that the needle did not retract after a vaccine was administered and the ma tried to engage the safety.Date occurred: thursday (b)(6) 2024.No injury.Both needle issues were from the same lot number both are lot # 1172469 exp: 12-31-26.Customer would like credit for 1 box.
Additional Manufacturer Narrative
Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.

• Brand Name: BD NEEDLE INTEGRA 25X1 RB TW
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19591572
• Report Number: 1213809-2024-00404
• Device Sequence Number: 19691450
• Product Code: MEG
• UDI-Device Identifier: 30382903053118
• UDI-Public: (01)30382903053118
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: Health Professional
• Device Catalogue Number: 305311
• Device Lot Number: 1172469
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/23/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown