MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305892

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Neuropathy (1983)

Event Date 07/28/2022

Event Type  Injury  

Event Description

It was reported that an adverse event without identified device or use problem occurred while using bd eclipse¿ needle.Patient complained of ongoing weakness and was referred to practice physio.The following information was provided by the initial reporter: patient was followed up by practice doctor and in emergency department with no evidence of any injury found.Currently attending in practice physio.Patient has blamed the b12 injection and in particular has homed in on the needle as he feels it was blunt or there was a problem with it and this has caused him injury.As the patient continued to complain about ongoing weakness following injection the gp referred him to the practice physio.This was for an assessment and exercise plan to help strengthen any weakness.There was no reported weakness prior to the patient receiving the injection.Patient has sited the arm and hand weakness as a reason he cannot work.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an adverse event without identified device or use problem occurred while using bd eclipse¿ needle.Patient complained of ongoing weakness and was referred to practice physio.The following information was provided by the initial reporter: patient was followed up by practice doctor and in ed with no evidence of any injury found.Currently attending in practice physio.Patient has blamed the b12 injection and in particular has homed in on the needle as he feels it was blunt or there was a problem with it and this has caused him injury.As the patient continued to complain about ongoing weakness following injection the gp referred him to the practice physio.This was for an assessment and exercise plan to help strengthen any weakness.There was no reported weakness prior to the patient receiving the injection.Patient has sited the arm and hand weakness as a reason he cannot work.A needle form this lot number 211007, was used to administer an intra-muscular b12 injection to a patient on 28/07/2022 in coleraine treatment room.On insertion of needle in to the deltoid muscle in the right arm.Site felt hard and difficult to insert needle as per nurse.Patient communicated that the injection during administration was more painful than normal.Post administration patient complained of pins and needles and tingling in his arm radiating to hands and fingers.Patient was followed up by practice doctor and in ed with no evidence of any injury found.Currently attending in practice physio.Patient has blamed the b12 injection and in particular has homed in on the needle as he feels it was blunt or there was a problem with it and this has caused him injury.Another nurse has also stated having the same problem with a different patient when administering a b12 injection, she found injection site firm/ tough to penetrate.This box of needles have been removed from use, one has been checked and no issue noted with flow through the needle with h2o.I wish to raise this concern in case there is a problem with this lot number 2112007.

Manufacturer Narrative

H.6.Investigation summary: a device history record review was completed for provided material number 305892 and lot number 2112007.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.Ninety-five (95) samples from the affected lot number were returned for evaluation by our quality engineer team.Through examination of the samples, one of the needles was found to be dull, confirming the reported issue.This defect could have resulted from the needle manufacturing process or at the cannula supplier location.During the assembly process, an in-line camera system inspects all product for signs of defect and automatically rejects any faulty product.Cannula point condition is tested every thirty minutes and a penetrability test is performed for each lot released.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15433597
• MDR Text Key: 300034555
• Report Number: 3002682307-2022-00239
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 305892
• Device Lot Number: 2112007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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): Required Intervention