MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE

Catalog Number 302540

Device Problem Material Separation (1562)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: unknown.The date received by manufacturer has been used for this field.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 plastipak¿ syringes needle detached from the syringe.Report 1 of 2.The following was received by the initial reporter: by way of context, i share that i am communicating with a veterinary hospital, already established in the city for more than 15 years, and a client of several years.The situation that occurred today was as follows: during a blood sample in the jugular vein (in the neck) of a canine patient, it was required to use, as is protocol, a 3 ml plastic syringe with a 22g x 25mm (0.70mm)(1") needle (ref 302540) with lot 2221167 and expiration 07/2027.The only manipulation that was carried out on the needle was to confirm that it was properly screwed to the syringe, and in a matter of the latter it was only verified that the plunger worked properly (because i take advantage of commenting that we have had at least 4 failures with this one).When the patient was punctured, everything was fine, but when the plunger was pulled to collect the sample, the blood came out slowly and with the usual resistance, but for now the "vacuum" and resistance was lost as well.Being at this moment in which the needle detached from its screw-on area and remained inside the patient's jugular vein, thus generating an emergency situation where the needle was carefully withdrawn and gradually began to be inserted.To finish, i will attach 1 photo after the incident occurred today, and i will attach about 3 more where we have had failures with the plunger and 1 failure with the presence of liquid in the syringe without even having opened it (even the needle came separated inside the package).

Event Description

I am contacting you by this means to make a report on a 3 ml plastic syringe with a 22g x 25mm (0.70mm)(1") needle from the bd plastipak line.By way of context, i share that i am communicating with a veterinary hospital, already established in the city for more than 15 years, and a client of several years.The situation that occurred today was as follows: during a blood sample in the jugular vein (in the neck) of a canine patient, it was required to use, as is protocol, a 3 ml plastic syringe with a 22g x 25mm (0.70mm)(1") needle ref 302540 with lot 2221167 and expiration 07/2027.The only manipulation that was carried out on the needle was to confirm that it was properly screwed to the syringe, and in a matter of the latter it was only verified that the plunger worked properly (because i take advantage of commenting that we have had at least 4 failures with this one).When the patient was punctured, everything was fine, but when the plunger was pulled to collect the sample, the blood came out slowly and with the usual resistance, but for now the "vacuum" and resistance was lost as well.Being at this moment in which the needle detached from its screw-on area and remained inside the patient's jugular vein, thus generating an emergency situation where the needle was carefully withdrawn and gradually began to be inserted.It is the first time that a situation like this has happened to us, being above all loyal customers of this brand and this product.And that fortunately did not go further, but it does leave us very dissatisfied with respect to it and that is why i am making this report.

Manufacturer Narrative

One photo received by our quality team for investigation.Through visual inspection, 3ml syringe outside its primary packaging (blister), so the reported code and lot number cannot be confirmed.The syringe has liquid inside and the cannula is not assembled to the hub.No other defects or issues observed.Physical samples are required to further analyze the aspirate draw incident.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.Based on the teams investigation, possible root cause for needle pulled out of hub is associated with insufficient application of epoxy.Based on the quality team's investigation, we are not able to identify a root cause for aspirate draw difficulty related to our manufacturing process at this time.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17476347
• MDR Text Key: 320711896
• Report Number: 9614033-2023-00073
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 302540
• Device Lot Number: 2221167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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