MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SOLOSHOT¿ MINI AUTO-DISABLE SYRINGE

Catalog Number 302245

Device Problem Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 07/23/2017

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1508406, medical device expiration date: 2020-07-31, device manufacture date: 2015-08-24.Medical device lot #: 1509409, medical device expiration date: 2020-08-31, device manufacture date: 2015-09-08.Medical device lot #: 1707416, medical device expiration date: 2022-06-30, device manufacture date: 2017-07-20.Medical device lot #: 1709402, medical device expiration date: 2022-08-31, device manufacture date: 2017-08-31.(b)(6).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 the bd soloshot¿ mini auto-disable syringe needles bent easily and caused needle stick injuries.However, there was no medical intervention reported.

Event Description

It was reported that the bd soloshot¿ mini auto-disable syringe needles bent easily and caused needle stick injuries.However, there was no medical intervention reported.

Manufacturer Narrative

Investigation summary: no samples or photos were returned for evaluation.Dhr reviews: 1709416: we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine 2019 (september 20-23rd, 2017) during which 57 visual inspections were carried out with 1 rejection noted (#9803) related to defective sealing but this would not affect whether or not the reported issue.Syringes were assembled in machines nº4101 and 4105 (#7258102 ¿ september 19-26th,, 2017) during which 386 visual inspections of 16 units each were performed with 1 rejection noted (#9628) related to defective marking which would not affect whether or not the reported defects.1709402: we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine 2019 (september 4-6th, 2017) during which 50 visual inspections were carried out with 0 defects noted.Syringes were assembled in machines nº4101 and 4105 and comes from two batches: -#7237283 (august 29 - september 5th, 2017) during which 614 visual inspections of 16 units each were performed with 0 defects noted.-#7244141 (september 5-12nd, 2017) during which 562 visual inspections of 16 units each were performed with 0 defects noted.1508406: we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine 2019 (august 30th - september 1st, 2015) during which 53 visual inspections were carried out with 0 defects noted.Syringes (#5233452) were assembled in machines nº4101 and 4105 (august 25 - september 2nd, 2015) during which 351 visual inspections of 16 units each were performed with 0 defects noted.1509409: we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine 2030 (september 8-14th, 2015) during which 54 visual inspections were carried out with 0 defects noted.Syringes were assembled in machines nº4101 and 4105 and comes from two batches: -#5257191 (september 15-22nd, 2015) during which 316 visual inspections of 16 units each were performed with 0 defects noted.-#5247207 (september 8-14th, 2015) during which 300 visual inspections of 16 units each were performed with 0 defects noted.Visual inspection of retained samples of 200 units of each lot show all needles are within specification, no bent or curved for lots 1709402, 1707416 and 1508406.1 bent/curved cannula was detected in lot 1509409.The affected syringes or pictures are not available for our evaluation so it is not possible to do an accurate investigation of the reported issue.Based on description of the issue and our retain sample evaluation, bd understands the reported issue is bent cannula and cannula embedding in shield which may cause needle prick injury.Bd determined these defects could be produced in the last step of the assembling machine, where the shield is introduced in the syringe.Due to some inefficient adjustment in assembling machine, the shield may have been incorrectly positioned bending the cannula.Since reported lots 1508406 and 1509409 were manufactured (august and september 2015), several improvements have been carried out to prevent reported.Issues: when bent cannula occurred, in addition shield is not correctly assembled into the syringe, it remains in a higher position.An in-line detection system that inspects 100% the shield position had been installed which rejects the defective ones.Material tweezers/clamps which place shield into syringe, was changed to prevent wear and tweezers are changed more often.Moreover, the design of tweezers had been improved to mitigate the incorrect position of shield.Modification in the shield feeder which permits correctly shield position before place into syringe.Since defect is confirmed due to retain sample evaluation, and taking into account our customer focus, a preventive action is required.A site corrective action has been initiated (fy18-52) in order to improve shield station and minimize as much as possible any possibility of occurrence in the future.

• Brand Name: BD SOLOSHOT¿ MINI AUTO-DISABLE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7844658
• MDR Text Key: 119151275
• Report Number: 3002682307-2018-00228
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

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
• Device Operator: Other
• Device Catalogue Number: 302245
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 08/14/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other