MAUDE Adverse Event Report: BECTON DICKINSON BD SOLOMED¿ 3ML SYRINGE; PISTON SYRINGE

Catalog Number 302633

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and/or lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h3.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 solomed¿ 3ml syringe the following was received by the initial reporter: we've received one more complaint in which the user reports difficult with the plunger while handling the medication.

Manufacturer Narrative

Samples and photos received by our quality team for investigation.Through visual evaluation, the sample received was opened in a way that could compromise the use of the syringe causing difficult plunger movement.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.To open the blister, the sample is taken by the ¿peel apart " and paper should be held with one hand, holding it with both hands, by the index fingers and thumb.After holding the packaging, open the blister by pulling the packaging in opposite directions.The paper and film in the packaging must not be be completely separated.The blister must be opened in a single movement, with moderate speed, and equal force in both hands.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.It is important to follow instruction for use for this product.

Event Description

Additional information received.We've received one more complaint in which the user reports difficult with the plunger while handling the medication, this complaint is associated to the same issue of the previous pr# (b)(4).The batches are potential lot numbers.Customer provided to us the additional information below.(f.Fenerich 25.Aug.2023) -material and batch #s; the batch of material 2073245, 2073242 and 2077110.I don't have information about the catalogue.Was there any clinical impact to patient or was medical intervention needed? in all cases, the medication was replaced for the client.Is it the same medication of pr# (b)(4).(betatrinta)? yes, all complaints are about betatrinta.Please describe the issue in details: the plunger got loose from the syringe, not being able to aspirate the medicine.Was any physical damage noted? does the plunger rod reach the end of barrel, is barrel cracked, is stopper well positioned, etc.? please describe: the customer did not point out any of these details.Please provide pictures/videos.Attached are the photos.24.Oct.23: add info received.What is the correct batch affected? are the batches of pr# 8662352 wrong? yes, they are incorrect.Shall batches be changed from 2073245, 2073242 & 2077110 to 2139737, 2202325 & 2202327? yes, for rm1530944 (8662352) replace with 2139737, 2202325 and 2202327 (correct batches) or is there a new complaint to batches 2139737, 2202325 & 2202327? not necessary.

• Brand Name: BD SOLOMED¿ 3ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17592257
• MDR Text Key: 321686395
• Report Number: 2243072-2023-01481
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 302633
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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