MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 305950

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using a 1 ml allergist tray with 27 g x 1/2 in.Bd safetyglide¿ permanently attached, regular bevel needle, the needle detached and remained in patient.It was also reported that the plunger also broke in half cutting the nurse with a piece of the plunger.While it is unknown if medical intervention was needed, no medical intervention was reported at this time.

Manufacturer Narrative

Investigation: summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Device history record review ¿ a review of the device history record was completed for batch # (b)(4).All inspections were performed per the applicable operations qc specifications.Syringe assembly - there were two (2) batches of material# (b)(4) (syringe 1.0ml asm 27ga 1/2in sg (b)(4)) which went into finished batch# (b)(4).Batch# (b)(4).Date(s) of manufacture: 07feb2017 thru 21feb2017.Machine(s) manufactured on: ga.Batch# (b)(4).Date(s) of manufacture: 28feb2017 thru 07mar2017.Machine(s) manufactured on: gb.Needle assembly- there were three (3) batches of material# (b)(4) (needle sf asm 27ga.555in sg orange) which went into finished batch# (b)(4).Batch# (b)(4).Date(s) of manufacture: 26jan2017 thru 01feb2017 machine(s) manufactured on: line 5.Batch# (b)(4).Date(s) of manufacture: 15feb2017 thru 21feb2017 machine(s) manufactured on: line 5.Batch# (b)(4).Date(s) of manufacture: 06mar2017 machine(s) manufactured on: line 6.There were two (2) notifications, (b)(4) ¿ broken thumb press and (b)(4) ¿ bent plungers.Noted during review of the above listed batches.Identified defective components/materials were dispositioned as deemed appropriate, prior to closure of each individual notification listed above.

• Brand Name: 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6817779
• MDR Text Key: 83537180
• Report Number: 1920898-2017-00167
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 305950
• Device Lot Number: 7026754
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other