MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305127
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.2nd batch reported: batch: 3320216, batch creation date: 2023-11-16, batch expiration date: 2029-02-28.
Event or Problem Description
Material# 305127, batch# 3320216 #3320217.It was reported by customer that needles break apart from the blue hub while pulling cap off.Verbatim: rcc received a complaint via email.Date: july 11, 2024.* name: xxxxxxx.* phone/extension: xxxxxxx.* department/service: pain management program / medicine services.* cost centre: (b)(4).Vendor name: bd precisonglide needle 25g x 1 ½ ¿ tw (0.5mm x 40mm).Hmms item id: 3194.Manufacturer catalogue number: 305127.Vendor catalogue number: bd305127.Description of item: include lot number if available 3320216.Comments: we have had 2 needles break apart from the blue hub while pulling cap off ¿ there is concern of patient safety - as a physician is aware of a situation at lhsc where a patient has a needle lodged in their back.We have removed these needles with lot 3320216 and 3320217 from our exam rooms but will need replacements asap.
Additional Manufacturer Narrative
(b)(4).Follow up.It was reported the needles break apart from the blue hub while pulling cap off.A device history record review was completed by our quality engineer team for provided material number 305127 and lot numbers 3320216 and 3320217.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received material# 305127 batch# 3320216 #3320217.It was reported by customer that needles break apart from the blue hub while pulling cap off.Verbatim: rcc received a complaint via email.Email(s) attached.Date: july 11, 2024.Name: xxxxxxx.Phone/extension: xxxxxxx.Department/service: pain management program / medicine services.Cost centre: (b)(4).Vendor name: bd precisonglide needle 25g x 1 ½ ¿ tw (0.5mm x 40mm).Hmms item id: 3194.Manufacturer catalogue number: 305127.Vendor catalogue number: bd305127.Description of item: include lot number if available 3320216.Comments: we have had 2 needles break apart from the blue hub while pulling cap off ¿ there is concern of patient safety - as a physician is aware of a situation at lhsc where a patient has a needle lodged in their back.We have removed these needles with lot 3320216 and 3320217 from our exam rooms but will need replacements asap.

• Brand Name: NEEDLE 25X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19837475
• Report Number: 1911916-2024-00544
• Device Sequence Number: 6768710
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• 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): 08/30/2024

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: 305127
• Device Lot Number: 3320217
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown